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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 Series

Geometric 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

Page last updated: August 20, 2015

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