Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal

Treatments: Biological: Infanrix hexa; Biological: Prevenar; Biological: GSK1024805A; Biological: Varilrix; Biological: Havrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624819

2007-005392-34 (EudraCT Number)

111345 (Mth 12)

111347 (Mth 48) (Other Identifier)

111346 (Mth 24) (Other Identifier)

Details and patient eligibility

About

This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

Full description

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Enrollment: 524 patients

Sex: All

Ages: 28 to 32 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female between, and including, 28-30 months of age at the time of first blood sampling.
• Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
• Administration of any additional pneumococcal vaccine since end of 107046 study.
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
• Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
• Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

524 participants in 4 patient groups

Synflorix + Infanrix + Havrix and/or Varilrix Group

Experimental group

Description:

This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix).

Treatment:

Biological: GSK1024805A

Biological: Varilrix

Biological: Havrix

Biological: Infanrix hexa

Prevenar + Infanrix + Havrix and/or Varilrix Group

Active Comparator group

Description:

This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).

Treatment:

Biological: Varilrix

Biological: Havrix

Biological: Prevenar

Biological: Infanrix hexa

Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix

Experimental group

Description:

This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix).

Treatment:

Biological: GSK1024805A

Biological: Varilrix

Biological: Havrix

Biological: Prevenar

Biological: Infanrix hexa

Unprimed Group

Experimental group

Description:

This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study.

Treatment:

Biological: GSK1024805A