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

NCT00624819 | Completed Phase 3 Results

• 4 other identifiers: 111345 (Mth 12)111346 (Mth 24)111347 (Mth 48)2007-005392-34
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Keywords

Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal conjugate vaccine; Antibody persistence

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]

  A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.

  At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

• Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]

  A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

  At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

• Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]

  A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.

  At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)

Secondary Outcomes (43)

• Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]

  At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

• Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)]

  At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)

• Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]

  At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)

• Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]

  For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)

• Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]

  At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)

Study Arms (4)

Synflorix + Infanrix + Havrix and/or Varilrix Group

EXPERIMENTAL

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).

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

Prevenar + Infanrix + Havrix and/or Varilrix Group

ACTIVE COMPARATOR

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).

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

Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix

EXPERIMENTAL

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).

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

Unprimed Group

EXPERIMENTAL

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.

Biological: GSK1024805A

Interventions

GSK1024805A BIOLOGICAL

No vaccination in this trial

Also known as: Synflorix

Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix; Synflorix + Infanrix + Havrix and/or Varilrix Group; Unprimed Group

Prevenar BIOLOGICAL

No vaccination in this trial

Prevenar + Infanrix + Havrix and/or Varilrix Group; Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix

Infanrix hexa BIOLOGICAL

No vaccination in this trial

Prevenar + Infanrix + Havrix and/or Varilrix Group; Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix; Synflorix + Infanrix + Havrix and/or Varilrix Group

Havrix BIOLOGICAL

No vaccination in this trial

Prevenar + Infanrix + Havrix and/or Varilrix Group; Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix; Synflorix + Infanrix + Havrix and/or Varilrix Group

Varilrix BIOLOGICAL

No vaccination in this trial

Prevenar + Infanrix + Havrix and/or Varilrix Group; Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix; Synflorix + Infanrix + Havrix and/or Varilrix Group

Eligibility Criteria

• Age: 28 Months - 32 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, 31-503, Poland

Location

GSK Investigational Site

Oleśnica, 56-400, Poland

Location

GSK Investigational Site

Poznan, 61-709, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections; Haemophilus Infections

Interventions

PHiD-CV vaccine; Heptavalent Pneumococcal Conjugate Vaccine; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Viral Hepatitis Vaccines; Viral Vaccines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: March 3, 2008
• Primary Completion: June 2, 2008
• Study Completion: June 2, 2008
• Last Updated: January 27, 2021
• Results First Posted: March 18, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

PL (6)