Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Treatments: Biological: Infanrix™ hexa; Biological: Haemophilus influenzae type b- and meningococcal (vaccine); Biological: Meningitec™; Biological: Engerix-B; Biological: NeisVac-C™; Biological: Infanrix™ penta; Biological: Infanrix™ IPV/HIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322335

106679 (Other Identifier)

106672

106673 (Other Identifier)

106680 (Other Identifier)

106675 (Other Identifier)

Details and patient eligibility

About

This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Enrollment: 230 patients

Sex: All

Ages: 31 to 33 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
• Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

Exclusion criteria

• Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
• History of H. influenzae type b, meningococcal serogroup C diseases.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 3 patient groups

Menitorix/Pediarix Group

Experimental group

Description:

Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

Treatment:

Biological: Haemophilus influenzae type b- and meningococcal (vaccine)

Biological: Infanrix™ penta

Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group

Active Comparator group

Description:

Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

Treatment:

Biological: NeisVac-C™

Biological: Haemophilus influenzae type b- and meningococcal (vaccine)

Biological: Infanrix™ hexa

Biological: Engerix-B

Biological: Infanrix™ IPV/HIB

Infanrix hexa/Meningitec Group

Active Comparator group

Description:

Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.

Treatment:

Biological: Infanrix™ hexa

Biological: Meningitec™