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

Hepatitis B Clinical Trial

Official title:

Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611559
• Other study ID #: 110478
• Status: Completed
• Phase: Phase 4
• Start date: February 14, 2008
• Est. completion date: June 25, 2008

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: June 25, 2008
• Est. primary completion date: June 25, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 23 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

• Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.

• Collapse or shock-like state within 48 hours of vaccination.

• Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.

• Convulsions with or without fever, occurring within 3 days of vaccination

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Hepatitis B
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Infanrix™ penta
Subjects received a booster dose
• Infanrix™ hexa
Subjects received a booster dose

Locations

Country	Name	City	State
Russian Federation	GSK Investigational Site	Murmansk
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Syktyvkar

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose	Anti-HB antibodies cut-off value assessed were = 10 mIU/mL and = 100 mIU/mL; Number of subjects with cut-off = 10 mIU/mL one month after the booster dose was already presented in the primary outcomes	Before (Pre) and one month after (Post) the booster dose
Secondary	Anti-HB Antibodies Concentration	Concentration of anti-HB antibodies given as GMC in mIU/mL	Before (Pre) and one month after (Post) the booster dose
Secondary	Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose	Anti-PRP antibodies cut-off value assessed were = 0.15 µg/mL and = 1.0 µg/mL; Number of subjects with cut-off = 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes	Before (Pre) and one month after (Post) the booster dose
Secondary	Anti-PRP Antibodies Concentration	Concentration of anti-PRP antibodies given as GMC in µg/mL	Before (Pre) and one month after (Post) the booster dose
Secondary	Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose	Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was = 0.1 IU/mL	Before the booster dose administration (at baseline)
Secondary	Anti-diphtheria and Anti-tetanus Antibodies Concentration	Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL	Before (Pre) and one month after (Post) the booster dose
Secondary	Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose	Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were = 5 EL.U/mL	Before (Pre) and one month after (Post) the booster dose
Secondary	Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose	Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL	Before the booster dose administration (at baseline)
Secondary	Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose	Anti-poliovirus antibodies cut-off value assessed was = 8 ED50	Before the booster dose
Secondary	Anti-poliovirus Antibodies Titer	Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)	Before (Pre) and one month after (Post) the booster dose
Secondary	Number of Subjects Reporting Solicited Symptoms	Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite	Within the 4-day (Day 0-3) post-vaccination period
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AE)	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Within the 31-day (Day 0-30) post-vaccination period
Secondary	Number of Subjects Reporting Serious Adverse Events (SAE)	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above	Up to one month after the booster dose administration

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