SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT04681820 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT01369199 (13) NCT00337467 (13) NCT00098293 (13) NCT01368497 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT02725567 (10) NCT01614470 (10) NCT01423812 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NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT04625647 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT03058094 (3) NCT01282151 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02684591 (2) NCT02282267 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT03333343 (2) NCT00525473 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00969137 (2) NCT00834665 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT04687241 (2) NCT00005541 (2) NCT01242813 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT04309019 (2) NCT03720665 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04622072 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT03239145 (2) NCT04511533 (2) NCT00226551 (2) NCT02191891 (2) NCT04586270 (2) NCT04669535 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03991013 (2) NCT02500927 (2) NCT04657991 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04646824 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT04657289 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT04429542 (2) NCT01841463 (2) NCT03865511 (2) NCT03205267 (2) NCT01218477 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT04645225 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT04644315 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT04675008 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT04687423 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT03586453 (2) NCT01998295 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT04636437 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) 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NCT03678506 (1) NCT02146365 (1) NCT04310943 (1) NCT02619955 (1) NCT02934139 (1) NCT00400387 (1) NCT00375219 (1) NCT00149305 (1) NCT03520946 (1) NCT02787447 (1) NCT04501614 (1) NCT03166631 (1) NCT04213313 (1) NCT02078531 (1) NCT02349048 (1) NCT02981784 (1) NCT04636593 (1) NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT04500717 (1) NCT01074398 (1) NCT03134131 (1) NCT02455167 (1) NCT01004497 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) 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SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02097472

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.

NCT02097472 Pneumonia, Pneumococcal
MeSH:Pneumonia, Pneumococcal Pneumonia
HPO:Pneumonia

4 Interventions

Name: PATH-wSP

Description: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Type: Biological
Group Labels: 6

Adult Cohort 1, PATH-wSP, 600 mcg Adult Cohort 2, PATH-wSP, 1000 mcg Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1 PATH-wSP 300 mcg+Saline Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2 PATH-wSP 600 mcg+saline

Name: Synflorix

Description: 1 dose (0.5 mL) contains: 1 μg of each of the following pneumococcal polysaccharide serotypes: 1, 5, 6B, 7F, 9V, 14, and 23 F And 3 μg of the following pneumococcal polysaccharide serotypes: 4, 18C and 19F. The serotypes are conjugated to either: protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein
Type: Biological
Group Labels: 4

Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2: Active Control Only

Name: Pentavac

Description: Each PFS contains 0.5 ml (single dose): Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection.
Type: Biological
Group Labels: 4

Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2: Active Control Only

Name: Saline

Description: 0.9% Sodium Chloride Injection, USP
Type: Other
Group Labels: 6

Adult Cohort 1, Saline Adult Cohort 2, Saline Toddler Cohort 1 PATH-wSP 300 mcg+Saline Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+saline Toddler Cohort 2: Active Control Only


Primary Outcomes

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.

Measure: Number/Percent of Adult Subjects Experiencing Headache Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.

Measure: Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 1: does not interfere with activity Grade 2: interferes with activity

Measure: Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2: includes diffuse macular/maculopapular/morbilliform rash

Measure: Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Secondary Outcomes

Description: Measured with enzyme-linked immunosorbent assay (ELISA).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured with enzyme-linked immunosorbent assay (ELISA).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using meso scale discovery (MSD).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using ELISA

Measure: Fold Change in IgG Response to PspA-Fam1 (ELISA)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PhtD Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to BCH0785 Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to StkP Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PcpA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to SPWCA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PiuA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PiaA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Measure: Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Measure: Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Other Outcomes

Description: GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.

Measure: Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects

Time: 12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L460D

Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).. Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay. --- L460D ---

Measured with enzyme-linked immunosorbent assay (ELISA).. Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein. --- L460D ---

Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA. --- L460D ---

Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD. --- L460D ---

Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA). --- L460D ---

Fold Change in IgG Response to L460D Pneumococcal Protein (MSD). --- L460D ---



HPO Nodes


HPO:
HP:0002090: Pneumonia
Genes 280
TLL1 CHD7 TGIF1 KMT2D ACP5 PIGN JAK3 NOS1 SFTPB SRP54 MS4A1 NODAL USB1 CD79B SGCG ACTC1 CASP8 TGFB1 OFD1 CD19 CD247 NHLRC1 SHH NTRK1 EGFR LAMA3 PLOD1 FANCF JAK3 RAG2 PGM3 CACNA1C BTK IL2RG PIK3CD CREBBP KCNJ6 FMO3 ACTA1 TNFSF12 GATA6 ZAP70 PLOD1 UNC119 FGF8 GAS1 DNAI1 WAS GNPTAB FOXH1 CYBC1 LAMC2 RAG1 PEPD PDHA1 PMM2 PAFAH1B1 CD19 CD3D SIX3 CD81 DLL1 LTBP3 EP300 TNFRSF13B SIX3 GLI2 SMARCD2 TIMM8A MYH6 DCLRE1C ABCA3 IL7R TBC1D24 STAT3 CFB FOXH1 FOXP3 FCGR2A P4HTM AP3B1 POLA1 TK2 CDON PKHD1 TAF1 CDON NIPBL GRHL3 GAS1 EFEMP2 CRLF1 SLC35A1 SLC25A24 DOCK8 ZIC2 LEP AFF4 DDR2 CD3E PTPRC BLM RNU4ATAC TNFRSF13C KNSTRN CDON SELENON FOXH1 ORC6 RAG1 RNF168 SHH DISP1 CYBA IL7R CARD11 LONP1 COL11A2 CR2 FGF8 ZIC2 CARD11 CYBB NBN ICOS DNAJC21 DNMT3B DISP1 TGIF1 HLA-DQB1 ADA SETBP1 MED25 FOXH1 SLC35C1 ACADVL TDGF1 PNP SP110 SMC1A ICOS SREBF1 TDGF1 NBN DCLRE1C ALMS1 GLI2 MCIDAS FGF8 NCF1 RAG1 PTCH1 NADK2 IL2RG ZBTB24 ZAP70 GLI2 FGFR1 GAS1 TNFRSF13B GAS1 IFNGR1 CFTR COL11A2 CR2 SAMD9 CD247 TGIF1 TREX1 CARMIL2 TCIRG1 BLNK UBB SRP54 LAMB3 DISP1 RMRP TNFRSF13C NFKB1 STAG2 IRF8 PTCH1 SIX3 KPTN TBX20 TDGF1 CSPP1 IGHM BTK NFIX RNU4ATAC CXCR4 NFKB2 RAC1 CD27 TGIF1 ADA TBX20 ZIC2 MTHFD1 RAG2 GATA4 TNFRSF11A DZIP1L FGF8 KIAA0586 SHH TDGF1 RYR1 ODAD1 WDR1 CREBBP CITED2 DLL1 NCF2 TBCD SHH NODAL RAC2 SIX3 GBA PTCH1 DNAI2 ZIC2 TNFRSF13C ALMS1 PURA STAG2 DLL1 SBDS ICOS EFL1 ACP5 SFTPC CFAP410 MASP2 IL2RG IGLL1 AFF4 BTK LIG4 NFKB2 WDR19 CD55 CDON GAS8 EPM2A NKX2-1 RNF125 DCLRE1C NODAL LRBA ELANE MAN2B1 DLL1 PTCH1 HLA-DQA1 EXTL3 SLC35C1 MAN2B1 FOXN1 PRKCD GLI2 RANBP2 MID1 IL2RG FBLN5 NKX2-5 NODAL GFI1 TNFSF12 RAG2 ADA IL21R KDM6A OSTM1 ASAH1 DISP1 PANK2 FGFR1
SNP 0