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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01144663
First received: June 3, 2010
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.


Condition Intervention Phase
Infections, Meningococcal
Biological: Meningococcal vaccine GSK134612
Biological: MenC-CRM197
Biological: MenC-TT
Biological: DTPa-HBV-IPV/Hib
Biological: Pneumococcal conjugate vaccine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine. [ Time Frame: One month after the last primary vaccination dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine (on secondary readouts). [ Time Frame: Pre-vaccination, one month after the final priming vaccination, pre-booster and one month post-booster dose. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the co-administered pneumococcal conjugate vaccine. [ Time Frame: Pre-vaccination, one month after the final priming vaccination, pre-booster and one month post-booster dose. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the co-administered DTPa-HBV-IPV/Hib vaccine. [ Time Frame: Pre-vaccination, one month after the final priming vaccination, pre-booster and one month post-booster dose ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: Day 0 to Day 7 after each vaccine dose ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: Day 0 to Day 30 after each vaccine dose ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: Throughout the study (from Day 0 to Month 16) ] [ Designated as safety issue: No ]
  • Specific adverse events [ Time Frame: Throughout the study (from Day 0 to Month 16) ] [ Designated as safety issue: No ]

Enrollment: 2095
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
3 primary doses of meningococcal vaccine GSK 134612 at 2, 3 and 4 months of age with a booster dose of meningococcal vaccine GSK 134612 at 12 months of age.
Biological: Meningococcal vaccine GSK134612
4- or 3-dose intramuscular injection
Biological: DTPa-HBV-IPV/Hib
4-dose intramuscular injection
Other Name: Infanrix hexa™
Biological: Pneumococcal conjugate vaccine
4-dose intramuscular injection
Experimental: Group B
2 primary doses of meningococcal vaccine GSK 134612 at 2 and 4 months of age with a booster dose of meningococcal GSK 134612 at 12 months of age.
Biological: Meningococcal vaccine GSK134612
4- or 3-dose intramuscular injection
Biological: DTPa-HBV-IPV/Hib
4-dose intramuscular injection
Other Name: Infanrix hexa™
Biological: Pneumococcal conjugate vaccine
4-dose intramuscular injection
Active Comparator: Group C
2 primary doses of MenC-CRM197 at 2 and 4 months of age with a booster dose of MenC-CRM197 at 12 months of age.
Biological: MenC-CRM197
3-dose intramuscular injection
Biological: DTPa-HBV-IPV/Hib
4-dose intramuscular injection
Other Name: Infanrix hexa™
Biological: Pneumococcal conjugate vaccine
4-dose intramuscular injection
Active Comparator: Group D
2 primary doses of MenC-TT at 2 and 4 months of age with a booster dose of MenC-TT at 12 months of age.
Biological: MenC-TT
3-dose intramuscular injection
Biological: DTPa-HBV-IPV/Hib
4-dose intramuscular injection
Other Name: Infanrix hexa™
Biological: Pneumococcal conjugate vaccine
4-dose intramuscular injection

Detailed Description:

The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.

  Eligibility

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

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
  • A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s) or guardian of the subject.
  • Free of obvious health problems 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 (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
  • 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 (pharmaceutical product or device).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, 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 the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted).
  • Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting).

(Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator).

- Administration of immunoglobulins and/ or any blood products since birth or planned administration during the study period.

  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: NCT01144663

  Show 49 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01144663     History of Changes
Other Study ID Numbers: 113369
Study First Received: June 3, 2010
Last Updated: May 1, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Germany: Paul-Ehrlich-Institut
Estonia: Ministry of Social Affairs

Keywords provided by GlaxoSmithKline:
Infants
conjugate vaccine
immunogenicity
meningococcal vaccine
non-inferiority
co-administration

Additional relevant MeSH terms:
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 20, 2014