Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaccines, Pneumococcal
Intervention: 13-valent pneumococcal conjugate vaccine (Biological); 7-valent pneumococcal conjugate vaccine (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a
13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal
conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3,
4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
Clinical Details
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant SeriesGeometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose Percentage of Participants Reporting Pre-Specified Local Reactions Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Eligibility
Minimum age: 56 Days.
Maximum age: 112 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Aged 2 months (56 to 112 days) at time of enrollment.
2. Available for entire study period and whose parent(s) or 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) or 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
hepatitis B vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, or 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 or H influenzae
type b.
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. 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 and Contacts
Bad Kreuznach 55543, Germany
Bad Saulgau 88348, Germany
Bad Sobernheim 55566, Germany
Berlin 13355, Germany
Berlin 10967, Germany
Berlin 10551, Germany
Berlin 13409, Germany
Berlin 13507, Germany
Berlin 13627, Germany
Birkenfeld 75217, Germany
Bobingen 86399, Germany
Bramsche 49565, Germany
Bretten 75015, Germany
Cham 93413, Germany
Ehingen 89584, Germany
Erlangen 91056, Germany
Eschwege 37269, Germany
Flensburg 24939, Germany
Gau-Odernheim 55239, Germany
Hamburg 22763, Germany
Herzogenaurach 91074, Germany
Hoechberg 97204, Germany
Kehl 77694, Germany
Kiel 24111, Germany
Kleve 47533, Germany
Krefeld 47798, Germany
Ludwigshafen 67059, Germany
Luebeck 23568, Germany
Mainz 55101, Germany
Metzingen 72555, Germany
Minden 32427, Germany
Muenster 48159, Germany
Muenster 48165, Germany
Neumuenster 24534, Germany
Neumünster 24534, Germany
Neustadt/Aisch 91413, Germany
Niebuell 25899, Germany
Nuernberg 90473, Germany
Nuernberg 90482, Germany
Oberkirch 77704, Germany
Olching 82140, Germany
Pforzheim 75172, Germany
Porta Westfalica 32457, Germany
Ravensburg 88214, Germany
Tettnang 88069, Germany
Vellmar 34246, Germany
Weiden 92637, Germany
Weilheim 82362, Germany
Welzheim 73642, Germany
Wiesbaden 65205, Germany
Zirndorf 90513, Germany
Additional Information
Starting date: October 2006
Last updated: June 28, 2012
|