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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00366548
• Date of registration: 17/08/2006
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00366548
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Poland

Contacts

• Name: Trial Manager
• Affiliation: For Poland, [e-mail]

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion 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 ?-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies [eg, Synagis]).



Age minimum: 42 Days
Age maximum: 98 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal

Intervention(s)

Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80

Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

Primary Outcome(s)

Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (at 5 months of age)]

Percentage of Participants Achieving Antibody Level =0.35µg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series [Time Frame: One month after 3-dose infant series (at 5 months of age)]

Secondary Outcome(s)

Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose [Time Frame: one month after the toddler dose (at 13 months of age)]

Percentage of Participants Achieving Antibody Level = 0.35 µg/mL in the 13vPnC Group After the Toddler Dose [Time Frame: one month after the toddler dose (at 13 months of age)]

Secondary ID(s)

6096A1-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00366548