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Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

Primary Purpose

Poliomyelitis, Tetanus, Acellular Pertussis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered

Eligibility Criteria

undefined - 7 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks). Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period. Administration of immunosuppressants or other immune-modifying drugs from birth. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease. Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

At M7: Antibodies to PRP, MenC HBsAg

Secondary Outcome Measures

At M7: Abs. to all vaccine antigens
At M6: Abs. to PRP & MenC
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

Full Information

First Posted
July 14, 2006
Last Updated
January 3, 2020
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00352963
Brief Title
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
Official Title
Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2003 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 16, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Tetanus, Acellular Pertussis, Hepatitis B, Diphtheria
Keywords
Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
Primary Outcome Measure Information:
Title
At M7: Antibodies to PRP, MenC HBsAg
Secondary Outcome Measure Information:
Title
At M7: Abs. to all vaccine antigens
Title
At M6: Abs. to PRP & MenC
Title
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks). Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period. Administration of immunosuppressants or other immune-modifying drugs from birth. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease. Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
GSK Investigational Site
City
Almeira
ZIP/Postal Code
4009
Country
Spain
Facility Name
GSK Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
GSK Investigational Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
GSK Investigational Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
GSK Investigational Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
GSK Investigational Site
City
Leganes
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Móstoles/Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
GSK Investigational Site
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
GSK Investigational Site
City
Velez, Malaga
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=337
Citations:
PubMed Identifier
16874171
Citation
Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Jacquet JM, Collard A, Schuerman L; Spanish DTaP-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B vaccine coadministered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Aug;25(8):713-20. doi: 10.1097/01.inf.0000227725.61495.c4.
Results Reference
background
PubMed Identifier
17195697
Citation
Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-Del-Ri M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Collard A, Boutriau D, Schuerman L, Jacquet JM; Spanish DTPa-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months. Pediatr Infect Dis J. 2007 Jan;26(1):1-7. doi: 10.1097/01.inf.0000247070.60063.09.
Results Reference
background
Citation
Jeanne Jaquet et al. Co-administration of DTPa-HBV-IPV/Hib with two doses of a MenC-TT conjugate vaccine in primary vaccination - 23rd Annual Meeting ESPID, Valencia, Spain, 18-20 May 2005.
Results Reference
background
Citation
Tejedor et al. Immunogenicity and reactogenicity of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C-tetanus toxoid conjugate (Hib-MenC-TT) Vaccine co-administered with a pentavalent DTPa-HBV-IPV vaccine at 2, 4 and 6 months - 24th Annual Meeting ESPID, Basel, Switzerland, 03-05 May 2006.
Results Reference
background
PubMed Identifier
17881905
Citation
Tozzi AE, Azzari C, Bartolozzi G, Esposito S, Fara GM, Giudice ML. Can hexavalent vaccines be simultaneously administered with pneumococcal or meningococcal conjugate vaccines? Hum Vaccin. 2007 Nov-Dec;3(6):252-9. doi: 10.4161/hv.4626. Epub 2007 Jun 23.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

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