Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

NCT00611559 | Completed Phase 4 Results

• 1 other identifier: 110478
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 3

Brief Summary

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

Conditions

Poliomyelitis; Acellular Pertussis; Tetanus; Diphtheria; Hepatitis B

Keywords

Infanrix hexa; combined vaccine

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose

  Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)

  One month after the booster dose

• Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose

  Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)

  One month after the booster dose

• Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

  Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)

  One month after the booster dose

• Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

  Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)

  One month after the booster dose

• Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose

  Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)

  One month after the booster dose

Secondary Outcomes (13)

• Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose

  Before (Pre) and one month after (Post) the booster dose

• Anti-HB Antibodies Concentration

  Before (Pre) and one month after (Post) the booster dose

• Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose

  Before (Pre) and one month after (Post) the booster dose

• Anti-PRP Antibodies Concentration

  Before (Pre) and one month after (Post) the booster dose

• Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose

  Before the booster dose administration (at baseline)

Study Arms (3)

Infanrix hexa Preservative-Free Formulation Group

EXPERIMENTAL

Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa

Biological: Infanrix™ hexa

Infanrix hexa Preservative-Containing Formulation Group

ACTIVE COMPARATOR

Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa

Biological: Infanrix™ hexa

Infanrix penta Preservative-Free Formulation Group

ACTIVE COMPARATOR

Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.

Biological: Infanrix™ penta

Interventions

Infanrix™ penta BIOLOGICAL

Subjects received a booster dose

Also known as: Pediarix

Infanrix penta Preservative-Free Formulation Group

Infanrix™ hexa BIOLOGICAL

Subjects received a booster dose

Infanrix hexa Preservative-Containing Formulation Group; Infanrix hexa Preservative-Free Formulation Group

Eligibility Criteria

• Age: 18 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
• A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
• 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.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
• Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.
• Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.
• History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Any of the following adverse events having occurred after previous administration of DTP vaccine:
• Hypersensitivity reaction due to the vaccine.
• Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
• Any of the following adverse events having occurred after previous administration of DTP vaccine:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Murmansk, 183046, Russia

Location

GSK Investigational Site

Perm, 614022, Russia

Location

GSK Investigational Site

Syktyvkar, 167000, Russia

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

Poliomyelitis; Tetanus; Diphtheria; Hepatitis B

Interventions

PEDIARIX

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Corynebacterium Infections; Actinomycetales Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: February 14, 2008
• Primary Completion: June 25, 2008
• Study Completion: June 25, 2008
• Last Updated: June 6, 2018
• Results First Posted: August 10, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

RU (3)