Study To Evaluate a 13-Valent Pneumococcal Conjugate Vaccine in Infants - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384059

Purpose

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.

Condition	Intervention	Phase
Vaccines, Pneumococcal	Biological: 13-valent Pneumococcal Conjugate Vaccine Biological: 7vPnC Biological: Pediacel Biological: NeisVac-C Biological: Menitorix	Phase III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom

Further study details as provided by Wyeth:

Primary Outcome Measures:

To compare immunogenicity of 13vPnC to Prevenar using serotype-specific serum IgG antibody levels; to evaluate immunogenicity of antigens in concomitant vaccines; to assess safety by local injection site reaction and systemic events, and adverse events. [ Time Frame: 5 and 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	286
Study Start Date:	October 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine 1 dose at 2, 4 and 12 months of age Biological: Pediacel concomittant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age Biological: NeisVac-C concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age Biological: Menitorix concomittant vaccine, both at arm 1 and at arm 2, at 12 months of age
2: Active Comparator	Biological: 7vPnC 1 dose at 2, 4 and 12 months of age Biological: Pediacel concomittant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age Biological: NeisVac-C concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age Biological: Menitorix concomittant vaccine, both at arm 1 and at arm 2, at 12 months of age

Eligibility

Ages Eligible for Study:	42 Days to 98 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy 2-month old infants
Available for the entire study period

Exclusion Criteria:

Previous vaccination with any vaccine before the start of the study
Known contraindication to vaccination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384059

Locations

United Kingdom

Coventry, United Kingdom, CV6 4DD

Weston-Super-Mare, United Kingdom, BS22 6AJ

Ely, United Kingdom, CB7 4HF

Oxford, United Kingdom, OX3 9DU

London, United Kingdom, SW17 ORE

Southampton, United Kingdom, SO16 6YD

Co Antrim, United Kingdom, BT41 3AE

Atherstone, United Kingdom, CV9 1EU

Bristol, United Kingdom, BS2 8AE

Plymouth, United Kingdom, PL5 3JB

Bangor, United Kingdom, BT19 1NB

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For UK/Great Britian, ukmedinfo@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6096A1-007
Study First Received:	October 2, 2006
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00384059
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009