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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01340898
First received: April 14, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.


Condition Intervention Phase
Tetanus
Diphtheria
Haemophilus Influenzae Type b
Whole Cell Pertussis
Hepatitis B
Biological: Meningococcal vaccine GSK 134612
Biological: SynflorixTM
Biological: Infanrix-IPV/HiberixTM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with a titer equal to or above the cut-off value [ Time Frame: One month post-dose 3 (Month 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine in terms of number of subject with titers equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the co-administered vaccines in terms of number of subjects with concentrations equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ] [ Designated as safety issue: No ]
  • Number of subjects with solicited local and general symptoms [ Time Frame: Within 8 days (Day0 to Day7) after each vaccine dose ] [ Designated as safety issue: No ]
  • Number of subjects with unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to 30) after each vaccine dose ] [ Designated as safety issue: No ]
  • Number of subjects with serious adverse events [ Time Frame: Throughout the study period (Month 0 to Month 19) ] [ Designated as safety issue: No ]
  • Number of subjects with new onset of chronic illnesses [ Time Frame: Throughout the study period (Month 0 to Month 19) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody titers [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with vaccine response [ Time Frame: At Month 14 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the co-administered vaccines in terms of antibody concentrations [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ] [ Designated as safety issue: No ]

Enrollment: 753
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who receive 3 primary doses and 1 booster dose of the investigational vaccine, (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age).
Biological: Meningococcal vaccine GSK 134612
Intramuscular injection
Biological: SynflorixTM
Intramuscular injection
Biological: Infanrix-IPV/HiberixTM
Intramuscular injection
Experimental: Group B
Subjects who receive 1 primary dose and 1 booster dose of the investigational vaccine, (1 dose at 6 months of age followed by a booster dose at 15-18 months of age)
Biological: Meningococcal vaccine GSK 134612
Intramuscular injection
Biological: SynflorixTM
Intramuscular injection
Biological: Infanrix-IPV/HiberixTM
Intramuscular injection
Experimental: Group C
Subjects who receive 1 dose of the investigational vaccine, at 15-18 months of age
Biological: Meningococcal vaccine GSK 134612
Intramuscular injection
Biological: SynflorixTM
Intramuscular injection
Biological: Infanrix-IPV/HiberixTM
Intramuscular injection

Detailed Description:

This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Extended administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
  • History of receipt of meningococcal vaccine.
  • Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
  • History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of th
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340898

Locations
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Mexico
GSK Investigational Site
Durango, Mexico, 34000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01340898     History of Changes
Other Study ID Numbers: 114858
Study First Received: April 14, 2011
Last Updated: August 7, 2014
Health Authority: Lebanon: Republic of Lebanon, Ministry of Health
Turkey: Ministry of Health of Turkey

Keywords provided by GlaxoSmithKline:
meningococcal conjugate vaccine
serogroups A,C, W-135 or Y
meningococcal diseases
Immunogenicity
Neisseria meningitidis
co-administration
routine vaccines

Additional relevant MeSH terms:
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014