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A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03692871
Collaborator
(none)
2,409
Enrollment
76
Locations
2
Arms
27.4
Actual Duration (Months)
31.7
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

Condition or Disease Intervention/Treatment Phase
  • Biological: V114
  • Biological: Prevnar 13™
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2409 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Mar 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: V114

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Biological: V114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Other Names:
  • VAXNEUVANCE™
  • Pneumococcal 15-Valent Conjugate Vaccine

    		•
    Active Comparator: Prevnar 13™

    Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Biological: Prevnar 13™
    Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Solicited Injection-site Adverse Event [Up to Day 14 after each study vaccination]

      An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

    2. Percentage of Participants With a Solicited Systemic Adverse Event [Up to Day 14 after each study vaccination]

      An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

    3. Percentage of Participants With a Vaccine-related Serious Adverse Event [Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)]

      A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.

    Secondary Outcome Measures

    1. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) [30 days after Vaccination 3 (approximately 5 months after Vaccination 1)]

      The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

    2. GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) [Before Vaccination 4 (10-13 months after Vaccination 1)]

      The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

    3. GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) [30 days after Vaccination 4 (11-14 months after Vaccination 1)]

      The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

    4. Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) [30 days after Vaccination 3 (approximately 5 months after Vaccination 1)]

      The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    42 Days to 90 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator

    • Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent

    • Have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

    Exclusion Criteria:

    • History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease

    • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine

    • Known or suspected impairment of immunological function

    • History of congenital or acquired immunodeficiency

    • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

    • Known or history of functional or anatomic asplenia

    • Failure to thrive based on the clinical judgment of the investigator

    • Known coagulation disorder contraindicating intramuscular vaccination

    • History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)

    • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders

    • Received a dose of any pneumococcal vaccine prior to study entry

    • Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine

    • Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.

    • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study

    • Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Premier Health Research Center, LLC ( Site 0005) Downey California United States 90240
    2 Beach Pediatrics ( Site 0040) Huntington Beach California United States 92647
    3 Khruz Biotechnology Research Institute ( Site 0006) San Diego California United States 92102
    4 Kaiser Permanente - San Jose ( Site 0036) San Jose California United States 95119
    5 Kaiser Permanente - Santa Clara ( Site 0027) Santa Clara California United States 95051
    6 Children's Research, LLC ( Site 0025) Lake Mary Florida United States 32746
    7 Advanced Research For Health Improvement LLC ( Site 0030) Naples Florida United States 34102
    8 Pediatric Partners, P.A. ( Site 0010) Overland Park Kansas United States 66213
    9 Novak Center for Childrens Health ( Site 0033) Louisville Kentucky United States 40202
    10 Medpharmics, LLC ( Site 0037) Metairie Louisiana United States 70006
    11 Child Health Care Associates ( Site 0024) East Syracuse New York United States 13057
    12 Primedical Clinical Research ( Site 0035) Dayton Ohio United States 45419
    13 Allegheny Health & Wellness Pavilion West ( Site 0034) Erie Pennsylvania United States 16506
    14 CCP- Kid's Way ( Site 0008) Hermitage Pennsylvania United States 16148
    15 Thomas Jefferson University ( Site 0029) Philadelphia Pennsylvania United States 19107
    16 Medical Research South, LLC ( Site 0013) Charleston South Carolina United States 29407
    17 Pediatric Associates [Houston, TX] ( Site 0039) Houston Texas United States 77087
    18 University of Texas Medical Branch ( Site 0018) League City Texas United States 77573
    19 Tanner Clinic ( Site 0009) Layton Utah United States 84041
    20 Wee Care Pediatrics ( Site 0031) Layton Utah United States 84041
    21 Wee Care Pediatrics ( Site 0020) Roy Utah United States 84067
    22 University of Wisconsin American Family Children's Hospital ( Site 0023) Madison Wisconsin United States 53792
    23 Monash Children s Hospital ( Site 0093) Clayton Victoria Australia 3168
    24 Perth Children s Hospital ( Site 0092) Nedlands Australia 6009
    25 Children, Youth and Woman's Health Service ( Site 0094) North Adelaide Australia 5087
    26 Alberta Children s Hospital ( Site 0048) Calgary Alberta Canada T3B 6A8
    27 Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046) Vancouver British Columbia Canada V5Z 4H4
    28 IWK Health Centre [Halifax, Canada] ( Site 0043) Halifax Nova Scotia Canada B3K 6R8
    29 Hamilton Medical Research Group ( Site 0049) Hamilton Ontario Canada L8M 1K7
    30 Medicor Research Inc. ( Site 0041) Sudbury Ontario Canada P3A 1Y8
    31 CHU Sainte Justine ( Site 0047) Montreal Quebec Canada H3T 1C5
    32 McGill University Health Centre - Vaccine Study Centre ( Site 0045) Pierrefonds Quebec Canada H9H 4Y6
    33 CHUQ - Unite de Recherche en Sante Publique ( Site 0042) Quebec Canada G1E 7G9
    34 Espoon rokotetutkimuskeskus ( Site 0066) Espoo Finland 02230
    35 Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064) Helsinki Finland 00100
    36 Ita-Helsingin Rokotetutkimuskeskus ( Site 0065) Helsinki Finland 00930
    37 Jarvenpaan rokotetutkimuskeskus ( Site 0067) Jarvenpaa Finland 04400
    38 Kokkolan rokotetutkimusklinikka ( Site 0071) Kokkola Finland 67100
    39 Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072) Oulu Finland 90220
    40 Porin Rokotetutkimusklinikka ( Site 0069) Pori Finland 28100
    41 Seinajoki Vaccine Research Center ( Site 0070) Seinajoki Finland 60100
    42 Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063) Tampere Finland 33100
    43 Turun rokotetutkimuskeskus ( Site 0068) Turku Finland 20520
    44 Kinderarztpraxis ( Site 0124) Aschaffenburg Germany 63739
    45 Kinderarztpraxis ( Site 0123) Bramsche Germany 49565
    46 Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085) Hamburg Germany 22415
    47 Kinderarztpraxis ( Site 0081) Huerth Germany 50354
    48 Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122) Lauffen Germany 74348
    49 Kinderarztpraxis ( Site 0080) Moenchengladbach Germany 41236
    50 Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091) Munchengladbach Germany 41236
    51 Kinderarztpraxis ( Site 0084) Schoenau Germany 83471
    52 Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083) Wolfsburg Germany 38448
    53 Soroka University Medical Center ( Site 0077) Beer Sheva Israel 8410101
    54 Soroka University Medical Center - Ramot Family health center ( Site 0078) Beer-Sheva Israel 8471844
    55 Rambam Medical Center ( Site 0076) Haifa Israel 3109601
    56 Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138) Haifa Israel 3515427
    57 Rambam Medical Center- Neve David Family Health Center ( Site 0139) Haifa Israel 3542129
    58 Soroka Medical Center_ Hura Family health center ( Site 0137) Hura Israel 8573000
    59 Soroka University Medical Center - Rahat Family health center ( Site 0079) Rahat Israel 8535700
    60 Klinik Kesihatan Greentown ( Site 0132) Ipoh Perak Malaysia 30450
    61 Sarawak General Hospital ( Site 0107) Kuching Sarawak Malaysia 93586
    62 Hospital Sibu ( Site 0111) Sibu Sarawak Malaysia 96000
    63 Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108) Kuala Lumpur Malaysia 59100
    64 Klinik Kesihatan Pandamaran ( Site 0110) Pelabuhan Klang Malaysia 42000
    65 Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057) Lima Peru 15001
    66 Instituto de Investigacion Nutricional ( Site 0058) Lima Peru 15416
    67 Clinica Peruano Americana S.A. ( Site 0061) Trujillo Peru 13011
    68 Taichung Veterans General Hospital ( Site 0100) Taichung Taiwan 407
    69 National Taiwan University Hospital ( Site 0097) Taipei Taiwan 10002
    70 Mackay Memorial Hospital ( Site 0099) Taipei Taiwan 10491
    71 Chang Gung Medical Foundation. Linkou ( Site 0098) Taoyuan Taiwan 333
    72 Chulalongkorn University ( Site 0102) Bangkok Thailand 10330
    73 Siriraj Hospital ( Site 0101) Bangkok Thailand 10700
    74 Maharaj Nakorn Chiang Mai Hospital ( Site 0103) Chiang Mai Thailand 50200
    75 Prince of Songkla University, Faculty of Medicine ( Site 0105) Hat Yai Thailand 90110
    76 Srinagarind Hospital. Khon Kaen University ( Site 0104) Khon Kaen Thailand 40002

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT03692871
    Other Study ID Numbers:
    • V114-031
    • V114-031
    • 2018-003308-38
    First Posted:
    Oct 2, 2018
    Last Update Posted:
    May 10, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This study enrolled healthy infants. Other inclusion criteria applied.
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Period Title: Overall Study
    STARTED 1972 437
    COMPLETED 1847 400
    NOT COMPLETED 125 37

    Baseline Characteristics

    Arm/Group Title V114 Prevnar 13™ Total
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Total of all reporting groups
    Overall Participants 1972 437 2409
    Age (weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [weeks]
    8.7
    (1.5)
    8.8
    (1.5)
    8.7
    (1.5)
    Sex: Female, Male (Count of Participants)
    Female
    948
    48.1%
    227
    51.9%
    1175
    48.8%
    Male
    1024
    51.9%
    210
    48.1%
    1234
    51.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    293
    14.9%
    74
    16.9%
    367
    15.2%
    Not Hispanic or Latino
    1678
    85.1%
    362
    82.8%
    2040
    84.7%
    Unknown or Not Reported
    1
    0.1%
    1
    0.2%
    2
    0.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    64
    3.2%
    20
    4.6%
    84
    3.5%
    Asian
    730
    37%
    152
    34.8%
    882
    36.6%
    Native Hawaiian or Other Pacific Islander
    2
    0.1%
    1
    0.2%
    3
    0.1%
    Black or African American
    54
    2.7%
    19
    4.3%
    73
    3%
    White
    966
    49%
    214
    49%
    1180
    49%
    More than one race
    154
    7.8%
    31
    7.1%
    185
    7.7%
    Unknown or Not Reported
    2
    0.1%
    0
    0%
    2
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Solicited Injection-site Adverse Event
    Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
    Time Frame Up to Day 14 after each study vaccination

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study vaccination
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 1965 433
    Injection-site erythema
    43.9
    2.2%
    36.0
    8.2%
    Injection-site induration
    25.3
    1.3%
    25.6
    5.9%
    Injection-site pain
    42.9
    2.2%
    36.5
    8.4%
    Injection-site swelling
    27.9
    1.4%
    23.3
    5.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Injection-site erythema
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.003
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 7.9
    Confidence Interval (2-Sided) 95%
    2.8 to 12.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Injection-site induration
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.882
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -5.0 to 4.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Injection-site pain
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.014
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    1.3 to 11.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Injection-site swelling
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.051
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 4.6
    Confidence Interval (2-Sided) 95%
    0.0 to 8.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants With a Solicited Systemic Adverse Event
    Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
    Time Frame Up to Day 14 after each study vaccination

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study vaccination
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 1965 433
    Decreased appetite
    41.6
    2.1%
    36.0
    8.2%
    Irritability
    74.9
    3.8%
    69.3
    15.9%
    Somnolence
    55.4
    2.8%
    55.0
    12.6%
    Urticaria
    5.9
    0.3%
    6.7
    1.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Decreased appetite
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.033
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 5.5
    Confidence Interval (2-Sided) 95%
    0.4 to 10.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Irritability
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.016
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 5.6
    Confidence Interval (2-Sided) 95%
    1.0 to 10.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Somnolence
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.878
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -4.7 to 5.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Urticaria
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value = 0.503
    Comments
    Method Miettinen & Nurminen method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -3.8 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Percentage of Participants With a Vaccine-related Serious Adverse Event
    Description A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
    Time Frame Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study vaccination
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 1965 433
    Number [Percentage of participants]
    0.1
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection V114, Prevnar 13™
    Comments Percentage of participants with a vaccine-related SAE
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
    Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
    Time Frame 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 38 35
    Serotype 1
    1.15
    1.61
    Serotype 3
    0.86
    0.58
    Serotype 4
    1.41
    1.27
    Serotype 5
    1.48
    1.66
    Serotype 6A
    1.37
    3.19
    Serotype 6B
    1.69
    2.53
    Serotype 7F
    1.95
    2.92
    Serotype 9V
    1.47
    1.50
    Serotype 14
    4.38
    6.52
    Serotype 18C
    1.46
    1.54
    Serotype 19A
    1.63
    3.00
    Serotype 19F
    2.03
    2.78
    Serotype 23F
    1.17
    1.18
    Serotype 22F
    4.33
    0.05
    Serotype 33F
    1.58
    0.05
    5. Secondary Outcome
    Title GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
    Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
    Time Frame Before Vaccination 4 (10-13 months after Vaccination 1)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 38 40
    Serotype 1
    0.30
    0.47
    Serotype 3
    0.22
    0.13
    Serotype 4
    0.24
    0.31
    Serotype 5
    0.77
    0.89
    Serotype 6A
    0.32
    0.72
    Serotype 6B
    0.59
    0.61
    Serotype 7F
    0.57
    0.95
    Serotype 9V
    0.40
    0.46
    Serotype 14
    1.14
    2.22
    Serotype 18C
    0.35
    0.36
    Serotype 19A
    0.38
    0.81
    Serotype 19F
    0.41
    0.69
    Serotype 23F
    0.33
    0.37
    Serotype 22F
    1.24
    0.05
    Serotype 33F
    1.09
    0.05
    6. Secondary Outcome
    Title GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
    Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
    Time Frame 30 days after Vaccination 4 (11-14 months after Vaccination 1)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 34 39
    Serotype 1
    1.56
    1.96
    Serotype 3
    1.04
    0.79
    Serotype 4
    1.55
    1.61
    Serotype 5
    3.30
    3.60
    Serotype 6A
    4.18
    6.38
    Serotype 6B
    6.62
    6.75
    Serotype 7F
    4.01
    5.10
    Serotype 9V
    3.10
    3.09
    Serotype 14
    5.40
    7.15
    Serotype 18C
    3.21
    2.77
    Serotype 19A
    4.96
    6.47
    Serotype 19F
    4.48
    4.83
    Serotype 23F
    2.38
    3.04
    Serotype 22F
    9.83
    0.08
    Serotype 33F
    5.46
    0.10
    7. Secondary Outcome
    Title Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
    Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
    Time Frame 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Measure Participants 38 35
    Serotype 1
    97.4
    4.9%
    97.1
    22.2%
    Serotype 3
    89.5
    4.5%
    74.3
    17%
    Serotype 4
    94.7
    4.8%
    97.1
    22.2%
    Serotype 5
    97.4
    4.9%
    88.6
    20.3%
    Serotype 6A
    97.4
    4.9%
    97.1
    22.2%
    Serotype 6B
    92.1
    4.7%
    94.3
    21.6%
    Serotype 7F
    97.4
    4.9%
    100
    22.9%
    Serotype 9V
    97.4
    4.9%
    94.3
    21.6%
    Serotype 14
    100
    5.1%
    97.1
    22.2%
    Serotype 18C
    97.4
    4.9%
    94.3
    21.6%
    Serotype 19A
    94.7
    4.8%
    97.1
    22.2%
    Serotype 19F
    97.4
    4.9%
    100
    22.9%
    Serotype 23F
    89.5
    4.5%
    94.3
    21.6%
    Serotype 22F
    97.4
    4.9%
    2.9
    0.7%
    Serotype 33F
    86.8
    4.4%
    2.9
    0.7%

    Adverse Events

    Time Frame Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
    Adverse Event Reporting Description The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
    Arm/Group Title V114 Prevnar 13™
    Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    All Cause Mortality
    V114 Prevnar 13™
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1972 (0.1%) 1/437 (0.2%)
    Serious Adverse Events
    V114 Prevnar 13™
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 192/1965 (9.8%) 45/433 (10.4%)
    Blood and lymphatic system disorders
    Autoimmune haemolytic anaemia 1/1965 (0.1%) 1 0/433 (0%) 0
    Lymphadenitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Cardiac disorders
    Cardio-respiratory arrest 0/1965 (0%) 0 1/433 (0.2%) 1
    Cardiomyopathy 0/1965 (0%) 0 1/433 (0.2%) 1
    Congenital, familial and genetic disorders
    Congenital absence of bile ducts 0/1965 (0%) 0 1/433 (0.2%) 1
    Gastrointestinal disorders
    Anal fistula 1/1965 (0.1%) 1 0/433 (0%) 0
    Constipation 1/1965 (0.1%) 1 0/433 (0%) 0
    Diarrhoea 2/1965 (0.1%) 2 0/433 (0%) 0
    Diarrhoea haemorrhagic 0/1965 (0%) 0 1/433 (0.2%) 1
    Dysphagia 1/1965 (0.1%) 1 0/433 (0%) 0
    Enteritis 1/1965 (0.1%) 1 0/433 (0%) 0
    Enterocolitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Inguinal hernia 1/1965 (0.1%) 1 0/433 (0%) 0
    Stomatitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Upper gastrointestinal haemorrhage 1/1965 (0.1%) 1 0/433 (0%) 0
    Vomiting 2/1965 (0.1%) 2 0/433 (0%) 0
    General disorders
    Pyrexia 8/1965 (0.4%) 8 1/433 (0.2%) 1
    Hepatobiliary disorders
    Cholangitis 0/1965 (0%) 0 1/433 (0.2%) 1
    Immune system disorders
    Anaphylactic reaction 1/1965 (0.1%) 1 0/433 (0%) 0
    Infections and infestations
    Arthritis bacterial 1/1965 (0.1%) 1 0/433 (0%) 0
    Atypical pneumonia 1/1965 (0.1%) 1 0/433 (0%) 0
    Bacteraemia 1/1965 (0.1%) 1 0/433 (0%) 0
    Bronchiolitis 27/1965 (1.4%) 29 7/433 (1.6%) 10
    Bronchitis 8/1965 (0.4%) 8 2/433 (0.5%) 2
    Bronchitis viral 1/1965 (0.1%) 1 0/433 (0%) 0
    Cellulitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Coxsackie viral infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Croup infectious 2/1965 (0.1%) 2 0/433 (0%) 0
    Diarrhoea infectious 3/1965 (0.2%) 3 0/433 (0%) 0
    Enterovirus infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Escherichia pyelonephritis 8/1965 (0.4%) 8 1/433 (0.2%) 1
    Escherichia sepsis 1/1965 (0.1%) 1 0/433 (0%) 0
    Escherichia urinary tract infection 6/1965 (0.3%) 6 1/433 (0.2%) 1
    Exanthema subitum 7/1965 (0.4%) 7 1/433 (0.2%) 1
    Gastroenteritis 15/1965 (0.8%) 17 0/433 (0%) 0
    Gastroenteritis adenovirus 1/1965 (0.1%) 1 0/433 (0%) 0
    Gastroenteritis bacterial 1/1965 (0.1%) 1 0/433 (0%) 0
    Gastroenteritis norovirus 2/1965 (0.1%) 2 0/433 (0%) 0
    Gastroenteritis rotavirus 0/1965 (0%) 0 1/433 (0.2%) 1
    Gastroenteritis salmonella 4/1965 (0.2%) 4 0/433 (0%) 0
    Gastroenteritis shigella 1/1965 (0.1%) 1 0/433 (0%) 0
    Gastroenteritis viral 5/1965 (0.3%) 5 1/433 (0.2%) 1
    Hand-foot-and-mouth disease 3/1965 (0.2%) 3 0/433 (0%) 0
    Herpangina 3/1965 (0.2%) 3 1/433 (0.2%) 1
    Influenza 4/1965 (0.2%) 4 3/433 (0.7%) 3
    Laryngitis 0/1965 (0%) 0 1/433 (0.2%) 1
    Mastoiditis 1/1965 (0.1%) 1 0/433 (0%) 0
    Metapneumovirus infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Nasopharyngitis 3/1965 (0.2%) 3 0/433 (0%) 0
    Oral herpes 1/1965 (0.1%) 1 0/433 (0%) 0
    Otitis externa 0/1965 (0%) 0 1/433 (0.2%) 1
    Parainfluenzae virus infection 0/1965 (0%) 0 1/433 (0.2%) 1
    Pertussis 1/1965 (0.1%) 1 0/433 (0%) 0
    Pneumonia 12/1965 (0.6%) 13 4/433 (0.9%) 4
    Pneumonia influenzal 2/1965 (0.1%) 2 0/433 (0%) 0
    Pneumonia parainfluenzae viral 1/1965 (0.1%) 1 0/433 (0%) 0
    Pneumonia pneumococcal 1/1965 (0.1%) 1 0/433 (0%) 0
    Pneumonia respiratory syncytial viral 5/1965 (0.3%) 5 2/433 (0.5%) 2
    Pneumonia viral 7/1965 (0.4%) 7 0/433 (0%) 0
    Pyelonephritis acute 1/1965 (0.1%) 1 0/433 (0%) 0
    Rectal abscess 1/1965 (0.1%) 1 0/433 (0%) 0
    Respiratory syncytial virus bronchiolitis 9/1965 (0.5%) 10 4/433 (0.9%) 4
    Respiratory syncytial virus bronchitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Respiratory syncytial virus infection 2/1965 (0.1%) 2 0/433 (0%) 0
    Respiratory tract infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Respiratory tract infection viral 1/1965 (0.1%) 1 0/433 (0%) 0
    Sepsis 1/1965 (0.1%) 1 0/433 (0%) 0
    Tonsillitis 3/1965 (0.2%) 3 0/433 (0%) 0
    Tracheitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Upper respiratory tract infection 5/1965 (0.3%) 5 1/433 (0.2%) 1
    Urinary tract infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Urinary tract infection bacterial 2/1965 (0.1%) 3 1/433 (0.2%) 1
    Urinary tract infection enterococcal 1/1965 (0.1%) 1 0/433 (0%) 0
    Viral infection 4/1965 (0.2%) 4 0/433 (0%) 0
    Viral pharyngitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Viral upper respiratory tract infection 1/1965 (0.1%) 1 0/433 (0%) 0
    Injury, poisoning and procedural complications
    Accidental exposure to product 1/1965 (0.1%) 1 0/433 (0%) 0
    Bone contusion 1/1965 (0.1%) 1 0/433 (0%) 0
    Burns second degree 1/1965 (0.1%) 1 0/433 (0%) 0
    Chemical poisoning 1/1965 (0.1%) 1 0/433 (0%) 0
    Concussion 1/1965 (0.1%) 1 1/433 (0.2%) 1
    Craniocerebral injury 1/1965 (0.1%) 1 0/433 (0%) 0
    Fibula fracture 0/1965 (0%) 0 1/433 (0.2%) 1
    Head injury 0/1965 (0%) 0 2/433 (0.5%) 2
    Subdural haemorrhage 1/1965 (0.1%) 1 0/433 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/1965 (0.1%) 1 0/433 (0%) 0
    Failure to thrive 0/1965 (0%) 0 1/433 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis 1/1965 (0.1%) 1 0/433 (0%) 0
    Oligoarthritis 0/1965 (0%) 0 1/433 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatoblastoma 1/1965 (0.1%) 1 0/433 (0%) 0
    Nervous system disorders
    Epilepsy 0/1965 (0%) 0 1/433 (0.2%) 1
    Febrile convulsion 4/1965 (0.2%) 4 1/433 (0.2%) 1
    Haemorrhage intracranial 1/1965 (0.1%) 1 0/433 (0%) 0
    Myoclonus 1/1965 (0.1%) 1 0/433 (0%) 0
    Paroxysmal choreoathetosis 1/1965 (0.1%) 1 0/433 (0%) 0
    Seizure 1/1965 (0.1%) 1 0/433 (0%) 0
    Psychiatric disorders
    Sleep disorder 1/1965 (0.1%) 1 0/433 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy 1/1965 (0.1%) 1 0/433 (0%) 0
    Apnoea 1/1965 (0.1%) 1 0/433 (0%) 0
    Asthma 0/1965 (0%) 0 1/433 (0.2%) 1
    Bronchial hyperreactivity 1/1965 (0.1%) 1 0/433 (0%) 0
    Pharyngeal haemorrhage 1/1965 (0.1%) 1 0/433 (0%) 0
    Pneumonia aspiration 1/1965 (0.1%) 1 0/433 (0%) 0
    Respiratory distress 1/1965 (0.1%) 1 0/433 (0%) 0
    Wheezing 1/1965 (0.1%) 1 1/433 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Angioedema 1/1965 (0.1%) 1 0/433 (0%) 0
    Drug eruption 1/1965 (0.1%) 1 0/433 (0%) 0
    Urticaria 1/1965 (0.1%) 1 0/433 (0%) 0
    Vascular disorders
    Haematoma 1/1965 (0.1%) 1 0/433 (0%) 0
    Other (Not Including Serious) Adverse Events
    V114 Prevnar 13™
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1807/1965 (92%) 395/433 (91.2%)
    Gastrointestinal disorders
    Diarrhoea 188/1965 (9.6%) 235 40/433 (9.2%) 49
    Vomiting 116/1965 (5.9%) 135 19/433 (4.4%) 20
    General disorders
    Injection site erythema 863/1965 (43.9%) 1528 156/433 (36%) 272
    Injection site induration 497/1965 (25.3%) 885 111/433 (25.6%) 205
    Injection site pain 843/1965 (42.9%) 1580 158/433 (36.5%) 288
    Injection site swelling 549/1965 (27.9%) 929 101/433 (23.3%) 163
    Pyrexia 775/1965 (39.4%) 1533 176/433 (40.6%) 329
    Infections and infestations
    Nasopharyngitis 158/1965 (8%) 182 37/433 (8.5%) 41
    Upper respiratory tract infection 129/1965 (6.6%) 139 30/433 (6.9%) 32
    Metabolism and nutrition disorders
    Decreased appetite 817/1965 (41.6%) 1664 156/433 (36%) 302
    Nervous system disorders
    Somnolence 1088/1965 (55.4%) 2696 238/433 (55%) 590
    Psychiatric disorders
    Irritability 1472/1965 (74.9%) 5402 300/433 (69.3%) 1053
    Skin and subcutaneous tissue disorders
    Urticaria 115/1965 (5.9%) 139 29/433 (6.7%) 40

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The investigators agree to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.

    Results Point of Contact

    Name/Title Clinical Trials Disclosure
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT03692871
    Other Study ID Numbers:
    • V114-031
    • V114-031
    • 2018-003308-38
    First Posted:
    Oct 2, 2018
    Last Update Posted:
    May 10, 2022
    Last Verified:
    Apr 1, 2022