# GRADE: 15-valent pneumococcal conjugate vaccine (PCV15) use in children aged h1>MinusRelated PagesIntroduction
On June 22, 2022, ACIP recommended use of 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme LLC]) as an option for pneumococcal conjugate vaccination for persons aged <19 years according to currently recommended PCV13 dosing and schedules. A systematic review and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was employed to guide ACIP’s deliberations regarding use of this vaccine.
Methods
A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 among pediatric age groups for which the vaccine was approved. Since only immunogenicity and safety data were available for PCV15, the search included 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.]) efficacy or effectiveness studies to help interpret PCV15 immunogenicity study findings. GRADE assessment was performed for PCV15 studies only. As a basis for the GRADE evidence assessment, the policy question consisting of the population, intervention, comparison, and outcomes of interest was defined (Table 1).
Table 1: Policy Question and PICOTable 1: Policy Question and PICOPolicy question:Should PCV15 be routinely recommended for U.S. children <2 years of age as an option for pneumococcal conjugate vaccination according to currently recommended dosing and schedules?PopulationU.S. children <2 years of ageInterventionPCV15 according to dosing and schedules currently recommended for PCV13ComparisonPCV13 according to currently recommended dosing and schedulesOutcomesVaccine-type invasive pneumococcal disease, vaccine-type pneumonia, vaccine-type acute otitis media, vaccine-type pneumococcal deaths, serious adverse events following immunization
This systematic review leveraged strategies used in existing systematic reviews, which captured literature published between January 1994–December 2019 targeting PCV7, PCV10, and PCV13 using various dosing schedules in the general pediatric population. Specifically, we utilized:
- Systematic Review of Pneumococcal Conjugate Vaccine Dosing Schedules (Loo 2014); searched literature from January 1994 – September 2010
- Systematic Review of Pneumococcal Conjugate Vaccine Dosing Schedules and Products (Cohen 2017); searched literature from October 2010 – December 2016
- Updated literature search to Cohen 2017, which was conducted to review evidence regarding dosing schedule changes; searched literature from January 2017 – December 2019

In addition, we conducted a search of literature published during January 2010 – October 2021 from the following databases: Medline (OVID), Embase (OVID), Cochrane Library, CINAHL (EbscoHost), and Scopus (for WOS). The search terms are included in Appendix 1. The updated search sought to capture:
- Pneumococcal vaccine studies specifically targeting children with underlying medical conditions*, which were not captured in the previous literature searches
- Additional literature on pneumococcal vaccines published since January 2020 to update the previous systematic reviews evaluating PCV13 use in the general pediatric population

Search results were supplemented by an updated Pubmed search using “V114**” or “PCV15” and a search of clinicaltrials.gov using “V114”. Unpublished data were provided by the vaccine manufacturer.

Studies with primary data on PCV15 use in children <2 years were included . Seventy-one studies were initially identified; after screening, deduplication, and exclusion, 7 were included for GRADE. Characteristics of these studied are included in Appendix 2. No PCV15 studies directly assessed vaccine effectiveness against the critical outcomes.    Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group during calls and via an email survey in which Work Group members were asked to rank the relative importance of each outcome. Vaccine-type invasive pneumococcal disease, vaccine-type non-bacteremic pneumococcal pneumonia, vaccine-type acute otitis media, vaccine-type pneumococcal deaths, and serious adverse events (SAEs) following immunization were deemed to be critical outcomes (Table 2).

*Underlying medical conditions include cerebrospinal fluid leak; chronic heart disease; chronic lung disease; cochlear implant; diabetes mellitus; immunocompromising conditions (chronic renal failure or nephrotic syndrome; congenital or acquired asplenia or splenic dysfunction; congenital or acquired immunodeficiencies; diseases and conditions treated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and solid organ transplant; HIV infection; and sickle cell disease and other hemoglobinopathies).

**V114 is the name used for Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate
Table 2: Outcomes and RankingsTable 2: Outcomes and RankingsOutcomeImportance*Included in evidence profileVaccine-type invasive pneumococcal diseaseCriticalNo**Vaccine-type pneumoniaCriticalNo**Vaccine-type acute otitis mediaCriticalNo**Vaccine-type pneumococcal deathsCriticalNo**Serious adverse events following immunizationCriticalYes*Three options: 1. Critical; 2. Important but not critical; 3. Not important for decision making**No clinical evidence available; immunogenicity data used as proxy for vaccine effectiveness of outcomesTable 3a. Summary of Studies Reporting ImmunogenicityTable 3a. Summary of Studies Reporting ImmunogenicityAuthor, yearStudy design; population and ageInterventionN interventionN comparisonComparator vaccineIgG GMC ratios [range (serotype)]1Absolute difference in % seroresponders (serotype)2InterpretationStudy limitations (Risk of Bias)Platt, 2020(V114-008)Phase 2 RCT (proof of concept); healthy children, 6––12 weeksPCV153+1 (2,4, 6, 12––15m)350 (Lot 1)347 (Lot 2)347PCV13Post-dose 3Lot 1: 0.54 (6A) to 1.98 (3)Lot 2: 0.57 (6A) to 1.93 (3)Post-dose 4Lot 1: 0.67 (7F) to 1.44 (3)Lot 2: 0.66 (6A) to 1.48 (3)Post-dose 3Lot 1: -5.6 (6A) to 24.3 (3)Lot 2: -0.8 (19F) to 22.4 (3)Post-dose 4Lot 1: -1.1 (23F) to 8.6 (3)Lot 2: 0 (4, 5, 6A, 7F, 9V, 14, 18C) to 9.6 (3)**GMC ratios**Post-dose 3- PCV15 > PCV13 for 3/13 (Lot 1) and 4/13 (Lot 2) shared serotypes; significantly higher for st3 (Lot 1 and 2) and 23F (Lot 2)
- PCV15 (Lot 1 and 2) > PCV13 for 22F and 33F

Post-dose 4
- PCV15 > PCV13 for st3 and 6B (Lot 1) and st3 and 18 (Lot 2); significantly higher for st3 only (Lot 1 and 2)
- PCV15 (Lot 1 and 2) > PCV13 for 22F and 33F

**%seroresponders****Post-dose 3**
- PCV15 (Lot 1 and Lot 2) noninferior 3  to PCV13 for all 13 shared serotypes
- PCV15 > PCV13 for 9/13 (Lot 1) and 8/13 (Lot 2) shared st; significantly higher for st3 only (Lot 1 and 2)
- PCV15 (Lot 1 and 2) > PCV13 for 22F and 33F

**Post-dose 4**
- PCV15 > PCV13 for 5/13 (Lot 1) and 6/13 (Lot 2) shared st; significantly higher for st3 only (Lot 1 and 2)
- PCV15 = PCV13 for 5/13 (Lot 1) and 7/13 (Lot 2) shared st
- PCV15 (Lot 1 and 2) > PCV13 for 22F and 33F
Not seriousV114-029Merck, unpublishedPhase 3 RCT (pivotal study); healthy children, 42––90 daysPCV153+1 (2,4, 6, 12–15m); co-administration Pentacel, RECOMBIVAX HB, RotaTeq858856PCV13Post-dose 3:0.52 (6A) to 1.73 (3)Post-dose 4:0.60 (6A) to 1.35 (3)Post-dose 3-5 (6A) to 16 (3)Post-dose 4Not reported**GMC ratios****Post-dose 3**- PCV15 noninferior 4  to PCV13 for 12/13 (no for 6A) shared serotypes; statistically significantly higher for st3
- PCV15 statistically significantly higher to PCV13 for 22F and 33F (unique st)
- PCV15 > PCV13 for st3 only (statistically significant)
- PCV15 > PCV13 for 22F and 33F

**Post-dose 4**
- PCV15 noninferior 4  to PCV13 for all 13 shared serotypes; statistically significantly higher for st3
- PCV15 statistically significantly higher to PCV13 for 22F and 33F (unique st)
- Non-inferiority met for concomitant use
- PCV15 > PCV13 for st3 (statistically significant)
- PCV15 > PCV13 for 22F and 33F

**%seroresponders****Post-dose 3**
- PCV15 noninferior 5  to PCV13 for all 13 shared serotypes; statistically significantly higher for st3
- PCV15 statistically significantly higher to PCV13 for 22F and 33F (unique st)
- PCV15 > PCV13 for st 3 (statistically significant)
- PCV15 = PCV13 for 14 and 23F
- PCV15 > PCV13 for 22F and 33F

**Post-dose 4**
- Not reported
Not seriousV114-027Merck, unpublishedPhase 3 RCT (product interchangeability); healthy children, 42–90 daysGroup 2: PCV13 + PCV13 + PCV13 + PCV15181179Group 1: PCV13 @ 2,4,6, 12–15m0.83 (1) to 1.51 (18C)0 (6A, 7F, 9V, 14, 19F) to 6.5 (23F)**GMC ratio (post-dose 4):**- Group 2 > Group 1 for 7/13 shared st; significant for 6B, 14, 18C

**% seroresponders (post-dose 3):**
- Group 2 > Group 1 for 8/13 shared st; significant for 14 and 23F
- Group 2 = Group 1 for 5/13 st
- Group 2 >Group 1 for 33F
Not seriousGroup 3: PCV13 + PCV13 + PCV15 + PCV15178179Group 1: PCV13 @ 2,4,6, 12–15m0.84 (4 and 19A) to 1.44 (18C)-4.9 (4) to 5.9 (3)**GMC ratio (post-dose 4):**- Group 3 > Group 1 for 6/13 shared st; significant for 14 and 18C

**% seroresponders (post-dose 3):**
- Group 3 > Group 1 for 4/13 shared st; significant for st4
- Group 3 = Group 1 for 7F
- Group 3 >Group 1 for 22F and 33F
Group 4: PCV13 + PCV15 + PCV15 + PCV15179179Group 1: PCV13 @ 2,4,6, 12–15m0.77 (23F) to 1.08 (6B)-91.4 (23F) to 8.7 (3 and 6B)**GMC ratio (post-dose 4):**- Group 4 > Group 1 for 4/13 shared st

**% seroresponders (post-dose 3):**
- Group 4 > Group 1 for 5/13 shared st; significant for st3
- Group 4 > Underlying medical conditions include cerebrospinal fluid leak; chronic heart disease; chronic lung disease; cochlear implant; diabetes mellitus; immunocompromising conditions (chronic renal failure or nephrotic syndrome; congenital or acquired asplenia or splenic dysfunction; congenital or acquired immunodeficiencies; diseases and conditions treated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and solid organ transplant; HIV infection; and sickle cell disease and other hemoglobinopathies). noninferior3Group 1 for 22F
Group 5: PCV15 @ 2,4,6, 12–15m179179Group 1: PCV13 @ 2,4,6, 12–15m0.67 (7F) to 1.22 (3)-4.7 (19A) to 20.7 (3)**GMC ratio (post-dose 4):**- Group 5 > Group 1 for 2/13 shared st; significant for st3

**% seroresponders (post-dose 3):**
- Group 5 > Group 1 for 6/13 shared st; significant for st3
- Group 5 > Group 1 for 22F and 33F
V114-024Merck, unpublishedPhase 3 RCT (catch up); heathy children, 7 months – 17 yearsPCV15 (7–11m: 3 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1, dose 3 @ 8–12w PD2 AND >12m))6464PCV13 (3 doses)0.52 (6A) to 1.55 (3)-3.3 (6A and 6B) to 3.4 (3)**GMC ratio (post-dose 3):**- PCV15 > PCV13 for st3 (significant)
- PCV15 >PCV13 for 22F and 33F

**% seroresponders (post-dose 3):**
- PCV15 > PCV13 for st3
- PCV15 = PCV13 for 8/13 shared st
- PCV15 >PCV13 for 22F and 33F
Not seriousPCV15 (12–23m: 2 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1))6264PCV13 (2 doses)0.54 (6A) to 1.76 (3)-11.1 (6A) to 8.2 (3)**GMC ratio (post-dose 2):**- PCV15 > PCV13 for 5/13 shared st; significant for st3 and 18C
- PCV15 >PCV13 for 22F and 33F

**% seroresponders (post-dose 2):**
- PCV15 > PCV13 for 6/13 shared st; significant for st3 and 4
- PCV15 = PCV13 for 19F
- PCV15 >PCV13 for 22F and 33F
PCV15 (2–17y: 1 dose (>8w after previous PCV)177175PCV13 (1 dose)0.48 (4) to 1.60 (18C)-1.2 (4) to 8 (3)**GMC ratio (post-dose 1):**- PCV15 > PCV13 for 6/13 shared st; significant for st3 and 18C
- PCV15 >PCV13 for 22F and 33F

**% seroresponders (post-dose 1):**
- PCV15 > PCV13 for 5/13 shared st; significant for st3
- PCV15= PCV13 for 4/13 st
- PCV15 >PCV13 for 22F and 33F

RCT = randomized controlled trial; GMC = Geometric Mean Concentration; st = serotype; PCV15 > PCV13 = PCV15 had higher immune responses compared to PCV13
- Ratio calculated as [GMC (PCV15)]/[GMC (comparator vaccine)]; blood draws occurred 30 days or 1 month post-dose.
- Seroresponse: proportion of participants meeting IgG threshold value of >=0.35μg/mL; blood draws occurred 30 days or 1 month post-dose.
- The statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% confidence interval (CI) of the proportion difference (V114 − PCV13) being greater than −0.15 for each of the 13 shared serotypes.
- Noninferiority requires the lower bound of the 2-sided 95% CI for IgG GMC ratio (V114/PCV13) to be >0.5 (1-sided p-value <0.025)
- Noninferiority requires the lower bound of the 2-sided 95% CI for the difference in response rates (V114 –PCV13) to be >-10 percentage points (1-sided p-value <0.025)
Table 3b. Summary of Studies Reporting SafetyTable 3b. Summary of Studies Reporting SafetyAuthor, yearStudy Design; population and ageN interventionN comparisonComparator vaccineAbsolute % difference(% SAE PCV15 –% SAE comparator)*N related to vaccineStudy limitations (Risk of Bias)Platt, 2020(V114-008)Phase 2 RCT (proof of concept); healthy children, 6–12 weeks697 (lots 1 and 2 combined)347PCV1312Not seriousV114-029Merck, unpublishedPhase 3 RCT (pivotal study); healthy children, 42–90 days858855PCV130.80Not seriousV114-027Merck, unpublishedPhase 3 RCT (product interchangeability); healthy children, 42–90 daysGroup 2: PCV13 + PCV13 + PCV13 + PCV15 (booster)181179Group 1: PCV13 @ 2,4,6, 12–15m1.60Not seriousGroup 3: PCV13 + PCV13 + PCV15 + PCV15178179Group 1: PCV13 @ 2,4,6, 12–15m-3.3**1**Group 4: PCV13 + PCV15 + PCV15 + PCV15179179Group 1: PCV13 @ 2,4,6, 12–15m-1.60Group 5: PCV15 @ 2,4,6, 12–15m179179Group 1: PCV13 @ 2,4,6, 12–15m00V114-024Merck, unpublishedPhase 3 RCT (catch up); heathy children, 7 months – 17 yearsPCV15 (7–11m: 3 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1, dose 3 @ 8–12w PD2 AND >12m))6464PCV13 (3 doses)3.10Not seriousPCV15 (12–23m: 2 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1))6264PCV13 (2 doses)0.20PCV15 (2–17y: 1 dose (>8w after previous PCV))177175PCV13 (1 dose)00V114-031Merck, unpublishedPhase 3 RCT, full-term v. preterm infants, 41 – 90 days1965433PCV13-0.62Not serious
SAE = Serious adverse event following immunization; RCT = randomized controlled trial; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV15 = 15-valent pneumococcal conjugate vaccine*Reported serious adverse events include those that occurred after dose 1 through completion of study participation.

** SAE that occurred in Group 3 occurred after the second PCV13 dose. Merck data on file, P027 clinical study report section 16.2.7.1.3:  listing of participants with serious adverse events. Charlotte, NC: Merck Sharp & Dohme LLC; 2021
Table 4. Grade Summary of Findings TableTable 4. Grade Summary of Findings TableCertainty assessmentNo of patientsResultsCertaintyImportanceNo of studiesStudy designRisk of biasInconsistencyIndirectnessImprecisionOther considerationsPCV15InterventionPCV13comparisonRelative(95% CI)Absolute(95% CI)**Vaccine effectiveness: vaccine-type pneumococcal disease (assessed with immunogenicity data)****41-4**Randomized studiesNot seriousNot seriousSeriousaNot seriousNot serious25751685PCV15 noninferior to PCV13 for all 13 shared serotypes; statistically significantly higher immune response for st3
PCV15 statistically significantly higher immune responses to PCV13 for 22F and 33F (unique st)
2CriticalSerious adverse events following immunization**51-5**Randomized studiesNot seriousNot seriousVery seriousbNot seriousNot serious4/45400/21171.7 (0.19, 14.2)c—3Critical
No = number; PCV15 = 15-valent pneumococcal conjugate vaccine; PCV13 = 13-valent pneumococcal conjugate vaccine; st = serotype
- These are all immunogenicity studies and there are no correlates of protection for some critical outcomes considered
- Few vaccine-related serious adverse events reported; wide 95% CI of the relative risk cannot exclude the potential for increased harm or benefit
- Pooled estimate is based on V114-008 and V114-031 that had SAE reported. V114-027 was not included in the pooled estimate, since the SAE occurred in a group that received PCV15, but after receipt of PCV13 doses. Merck data on file, P027 clinical study report section 16.2.7.1.3: listing of participants with serious adverse events. Charlotte, NC: Merck Sharp & Dohme LLC; 2021
Table 5. Summary of Evidence for Outcomes of InterestTable 5. Summary of Evidence for Outcomes of InterestOutcomeImportanceIncluded in profileCertaintyVT- invasive pneumococcal diseaseCriticalNo*2VT- pneumoniaCriticalNo*2Vaccine-type acute otitis mediaCriticalNo*2Vaccine-type pneumococcal deathsCriticalNo*2Serious adverse events following immunizationCriticalYes3
*No clinical evidence available; immunogenicity data used as proxy for vaccine effectiveness of outcomes
Summary
The evidence type for use of PCV15 in children aged <2 years was determined to be 2 (moderate certainty of evidence) for VT-invasive pneumococcal disease, VT-pneumonia, VT-acute otitis media, and VT- pneumococcal deaths and was downgraded once for indirectness due to lack of correlates of protection for the critical outcomes considered. The evidence type for serious adverse events following immunization was 3 (low certainty of evidence); the evidence level for imprecision was downgraded two points to very serious for few vaccine-related serious adverse events reported and for the relative risk crossing 1. ACIP reviewed the results of both the GRADE evidence assessment and the Evidence to Recommendations (EtR) framework in February 2022. An updated EtR table was shared with ACIP in June 2022. On June 22, 2022, ACIP recommended use of PCV15 as an option for pneumococcal conjugate vaccination for persons aged <19 years according to currently recommended PCV13 dosing and schedules.
References
Loo JD, Conklin L, Deloria Knoll M, Fleming-Dutra K, et al. Methods for a Systematic Review of Pneumococcal Conjugate Vaccine Dosing Schedules. PIDJ. 2014; 33(1,S2); S182-S187.

Cohen OG. Pneumococcal Conjugate Vaccine (PCV) Product Assessment. Accessed August 2, 2021 at https://www.jhsph.edu/ivac/wp-content/uploads/2018/05/pcv-product-assessment-april-25-2017.pdf.

Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatric Infectious Diseases Journal 2020.

V114-029. Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

V114-027. A Study to Evaluate the Interchangeability of V114 and Prevnar 13TM in Healthy Infants (V114-027/PNEU-DIRECTION)

V114-024. Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)

V114-031. A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13TM in Healthy Infants (V114-031/PNEU-LINK)
AppendicesAppendix 1. Search strategyAppendix 1. Search strategyDatabaseStrategyRun DateRecords**Medline****(OVID)****1946–**(((pneumococcal OR pneumococci OR streptococcus pneumoni* OR s? pneumoni*) ADJ5 (vaccin* OR immunization* OR immunisation*)) OR pneumovax OR pnu immune vaccine* OR pnuimmune vaccine* OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”)ANDExp Child/ OR (Child* OR pediatric* OR paediatric*).ti,ab,kf,hw.ANDTrial* OR study OR studies OR rct* OR review.ti,pt.Limit English; 2010 –10/20/20212864**Embase****(OVID)****1988–**(((pneumococcal OR pneumococci OR streptococcus pneumoni* OR s? pneumoni*) ADJ5 (vaccin* OR immunization* OR immunisation*)) OR pneumovax OR pnu immune vaccine* OR pnuimmune vaccine* OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”)ANDExp Child/ OR (Child* OR pediatric* OR paediatric*).ti,ab,kw,hw.ANDTrial* OR study OR studies OR rct* OR review.ti,pt.NOTexp animal/ NOT exp human/Limit English; 2010 – ; not pubmed/medline ; not conference abstracts10/20/20213236
-2304duplicates

=932unique items
**Cochrane Library**[mh “pneumococcal vaccines”] OR (((pneumococcal OR pneumococci OR streptococcus pneumoni* OR s? pneumoni*) ADJ5 (vaccin* OR immunization* OR immunisation*)) OR pneumovax OR pnu immune vaccine* OR pnuimmune vaccine* OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”):ti,abAND[mh Child] OR (Child* OR pediatric* OR paediatric*):ti,abLimit English; 2010 –10/20/2021331
-192duplicates

=139unique items
**CINAHL****(EbscoHost)**(((pneumococcal OR pneumococci OR “streptococcus pneumoni*” OR “s? pneumoni*”) N5 (vaccin* OR immunization* OR immunisation*)) OR pneumovax OR “pnu immune vaccine*” OR “pnuimmune vaccine*” OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”)AND(Child* OR pediatric* OR paediatric*)Limit English; 2010 – ; exclude Medline records10/20/2021345
-267duplicates

=78unique items
**Scopus****TITLE-ABS-KEY**(((pneumococcal OR pneumococci OR “streptococcus pneumoni*” OR “s? pneumoni*”) W/5 (vaccin* OR immunization* OR immunisation*)) OR pneumovax OR “pnu immune vaccine*” OR “pnuimmune vaccine*” OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”) AND**TITLE-ABS-KEY**(Child* OR pediatric* OR paediatric*) AND NOT INDEX(medline)Limit English; 2010 – ;10/20/2021682
-492duplicates

=190unique items
Appendix 2. Studies Included in the Review of EvidenceAppendix 2. Studies Included in the Review of EvidenceAuthor, yearStudy designInterventionCountryAgeTotal populationN InterventionN comparisonOutcomesFunding sourcePlatt, 2020(V114-008)Phase 2 RCT (proof of concept); healthy childrenPCV153+1 (2,4, 6, 12–15m)Canada, Denmark, Finland, Israel, Spain, US6–12 weeks at enrollment1044350 (Lot 1)347 (Lot 2)347Immunogenicity, safetyMerckV114-029Merck, unpublishedPhase 3 RCT (pivotal study); healthy childrenPCV153+1 (2,4, 6, 12–15m); co-administration Pentacel, RECOMBIVAX HB, RotaTeqPuerto Rico, Thailand, Turkey, US42–90 days at enrollment1714858856Immunogenicity, safetyMerckV114-027Merck, unpublishedPhase 3 RCT (product interchangeability); healthy childrenGroup 1: PCV13 @ 2,4,6, 12–15mGroup 2: PCV13 + PCV13 + PCV13 + PCV15 (booster)Group 3: PCV13 + PCV13 + PCV15 + PCV15 (booster)Group 4: PCV13 + PCV15 + PCV15 + PCV15 (booster)Group 5: PCV15 @ 2,4,6, 12–15mPuerto Rico, Thailand, Turkey, US42–90 days at enrollment896Group 2 (n=181)Group 3 (n=178)Group 4(n=179)Group 5(n=179)Group 1 (n=179)Immunogenicity, safetyMerckV114-024Merck, unpublishedPhase 3 RCT (catch up); healthy children7–11m: 3 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1, dose 3 @ 8–12w PD2 AND >12m12–23m: 2 doses (dose 1 @ 0w, dose 2 @ 4–8w PD1)2–17y: 1 dose (>8w after previous PCV)Finland, Malaysia, Poland, Russia, Thailand7 months – 17 years6062–11m (n=64)12–23m (n=62)2–17y(n=177)2–11m (n=64)12–23m (n=64)2–17y(n=175)Immunogenicity, safetyMerckV114-031Merck, unpublishedPhase 3 RCT, full-term v. preterm infantsPCV153+1 (2,4, 6, 12–15m)Australia, Canada, Finland, Germany, Israel, Malaysia, Peru, Taiwan, Thailand, USFull-term (>37 wks) and preterm infants (<37 wks); 42–90 days at enrollment23981965433safetyMerck
RCT = randomized controlled trial; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV15 = 15-valent pneumococcal conjugate vaccine
Top of Page						Last Reviewed:  August 31, 2022Source: 	National Center for Immunization and Respiratory Diseases- Facebook
- Twitter
- LinkedIn
- Syndicate
homeACIP Home- Meeting Information
- Committee Information plus icon    - Role of the ACIP in CDC’s Vaccine Recommendations
  - Charter
  - Economics Studies 
- Committee Members plus icon    - ACIP Membership Roster 
- Apply for ACIP Membership
- Work Groups plus icon    - VaST Reports plus icon      - June 28, 2021
    - May 24, 2021
    - May 17, 2021
    - March 29, 2021 
- Recommendations plus icon    - Shared Clinical Decision-Making Recommendations 
- Evidence Based Recommendations plus icon    - About GRADE
  - Grade Evidence Tables
  - Evidence to Recommendations Frameworks 
Related Links- Vaccines & Immunizations
- Immunization Schedules
- VFC Resolutions
- Vaccine Information Statements (VISs)

 
Contact ACIP Secretariat
1600 Clifton Road, N.E., Mailstop A27Atlanta, GA 30329-4027acip@cdc.gov
- About CDC
- Contact Us
- 800-232-4636
FacebookTwitterInstagramLinkedInYoutubePinterestSnapchat-  CONTACT CDC  Contact UsCall 800-232-4636Email Us 
-  ABOUT CDC  - About CDC
- Jobs
- Funding
 
-  POLICIES  - Accessibility
- External Links
- Privacy
- Policies
- No Fear Act
- FOIA
- OIG
- Nondiscrimination
- Vulnerability Disclosure Policy
 
-  CONNECT WITH US  Facebook
Twitter
Instagram
LinkedIn

Youtube
Pinterest
Snapchat
Email

 
-  LANGUAGES  - Español
- 繁體中文
- Tiếng Việt
- 한국어
- Tagalog
- Русский
- العربية
- Kreyòl Ayisyen
- Français
- Polski
- Português
- Italiano
- Deutsch
- 日本語
- فارسی
- English
 
- U.S. Department of Health & Human Services
- Accessibility
- External Links
- Privacy
- Policies
- No Fear Act
- FOIA
- Nondiscrimination
- OIG
- Vulnerability Disclosure Policy
- USA.gov
SASstatsExit Notification / Disclaimer PolicyClose**Links with this icon  indicate that you are leaving the CDC website.**- The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
- Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
- You will be subject to the destination website's privacy policy when you follow the link.
- CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website.
			For more information on CDC's web notification policies, see Website Disclaimers.		CancelContinue