Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children

Laval University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Infanrix-hexa and Twinrix Junior; Biological: Infanrix-hexa

Study type: Interventional

Funder types: Other

Identifiers

NCT04294433

Study 11022017

Details and patient eligibility

About

The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

Full description

In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.

this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

Enrollment: 431 patients

Sex: All

Ages: 2 to 19 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Comparator group :
• Have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.
• Study groups:
• Have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.

Exclusion criteria

• Have received other doses of hepatitis B vaccine;

• Considered immunosuppressed;

• Have an autoimmune disease;

• Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;

• Have a bleeding disorder;

  • Have a significant developmental delay;
  • Have or plan to participate in other clinical studies with vaccines or products not licensed in Canada;
  • Have presented a serious clinical condition to the vaccines administered as part of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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431 participants in 3 patient groups

Infanrix-hexa+Infanrix-hexa+Infanrix-hexa

Active Comparator group

Description:

Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa

Treatment:

Biological: Infanrix-hexa

Infanrix-hexa+Infanrix-hexa

Experimental group

Description:

Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa

Treatment:

Biological: Infanrix-hexa

Infanrix-hexa+Twinrix Junior

Experimental group

Description:

Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively

Treatment:

Biological: Infanrix-hexa and Twinrix Junior