Booster and Catch-up Vaccination With Vaccine GSK1024850A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01030822
First received: December 10, 2009
Last updated: April 11, 2013
Last verified: July 2012
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.

This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.

The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.


Condition Intervention Phase
Streptococcus Pneumoniae
Pneumococcal Disease
Biological: Pneumococcal vaccine GSK1024850A
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: Booster Vaccination With Pneumococcal Vaccine GSK1024850A in Primed Children and Catch-up Vaccination in Unprimed Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine in primed subjects [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine in primed subjects [ Time Frame: Prior to booster vaccination, one month after booster vaccination and at approximately 24 months of age ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the investigational vaccine in unprimed subjects [ Time Frame: Prior to vaccination, one month post-dose 2, prior to and one month after the third (booster) vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of each solicited adverse event [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: After the first vaccination up to 31 days after the last vaccination. ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 9-18 months of age.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as a single dose
Experimental: Group B
Subjects previously primed with pneumococcal vaccine GSK1024850A in the first year of life and receiving a booster dose of GSK1024850A at 15-18 months of age.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as a single dose
Experimental: Group C
Unprimed subjects receiving a catch-up vaccination (2+1 schedule) in the second year of life.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, 3 doses

Detailed Description:

The study is randomized for primed subjects and non-randomized for unprimed subjects.

The protocol posting has been updated according to the amendment of the protocol dated 16 April 2010. The age range at the time of randomization of subjects primed in study NCT00814710 and the age range for booster vaccination of one of the groups has been extended.

  Eligibility

Ages Eligible for Study:   9 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

For primed subjects:

  • Completion of the full vaccination course in study NCT00814710.
  • 9-18 months of age at the time of randomization.
  • Group A: 9-18 months of age at the time of booster vaccination.
  • Group B: 15-18 months of age at the time of booster vaccination.

For unprimed subjects (Group C):

  • Enrolled in study NCT00814710.
  • 12-18 months of age at the time of first vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
  • 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.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal vaccine since the end of study NCT00814710.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  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: NCT01030822

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

Publications:
Lalwani S. et al. Impact of age on booster responses to 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in children in India. Abstract presented at the 6th Asian Congress of Pediatric Infectious Diseases (ACPID), Colombo, Sri Lanka, 28 Nov - 01 Dec 2012.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01030822     History of Changes
Other Study ID Numbers: 112909
Study First Received: December 10, 2009
Last Updated: April 11, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by GlaxoSmithKline:
Catch-up vaccination
Safety
Pneumococcal vaccine
Pneumococcal disease
Booster vaccination
Immunogenicity

ClinicalTrials.gov processed this record on October 21, 2014