Clinical trial NCT00366548: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official title: A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Keywords: Vaccine
Infant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 500
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.


Eligibility criteria: Inclusion criteria:

1. Aged 2 months (42 through 98 days) at the time of enrollment.
2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. In good health as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s)/legal guardian(s) were 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, or polio vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal 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.
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, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).

Primary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
timeFrame: One month after 3-dose infant series (at 5 months of age)
measure: Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
timeFrame: One month after 3-dose infant series (at 5 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
timeFrame: one month after the toddler dose (at 13 months of age)
measure: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
timeFrame: one month after the toddler dose (at 13 months of age)
Other outcomes:
measure: Percent of Participants Reporting Pre-Specified Local Reactions
timeFrame: Within 4-days after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events
timeFrame: Within 4-days after each dose
Locations:
city: Bydgoszcz
country: Poland
city: Debica
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lubartow
country: Poland
city: Lublin
country: Poland
city: Oborniki Slaskie
country: Poland
city: Poznan
country: Poland
city: Poznan
country: Poland
city: Siemianowice Slaskie
country: Poland
city: Torun
country: Poland
city: Trzebnica
country: Poland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.