Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Wyeth is now a wholly owned subsidiary of Pfizer286 enrolled

Overview

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

286

Conditions

Vaccines, Pneumococcal

Interventions

13-valent Pneumococcal Conjugate VaccineBIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age

7vPnCBIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4 and 12 months of age

PediacelBIOLOGICAL

concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

Eligibility

Sex: ALLMin age: 42 DaysMax age: 98 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 2 months (42 to 98 days) at the time of enrollment. 2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone. 3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator. 4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation. Exclusion Criteria: 1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib. 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). 11. Participation in another investigational trial. Participation in purely observational studies was acceptable. 12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Locations (11)

Unnamed facility

Atherstone, United Kingdom

Unnamed facility

Bangor, United Kingdom

Unnamed facility

Bristol, United Kingdom

Unnamed facility

Co Antrim, United Kingdom

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.

Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b \[Hib\](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid \[PT\], filamentous haemagglutinin, pertactin \[FHA\], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens \[FIM\] (≥2.2 EU/mL) are presented.

Time frame: One month after infant series dose 2 (5 months of age)

Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age)

Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age)

Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age)

Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose

Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Data from ClinicalTrials.gov

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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes