Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age - Full Text View

Purpose

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Condition	Intervention	Phase
Pneumococcal Disease Streptococcus Pneumoniae Vaccines	Biological: Synflorix Biological: Infanrix hexa Biological: Rotarix	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Pneumonia Tetanus

Drug Information available for: Boostrix Heptavalent pneumococcal conjugate vaccine Rotarix Adacel Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Concentration of Anti-Protein D Antibodies [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Concentration of Anti-Pneumococcal Antibodies [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Secondary Outcome Measures:

Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value [ Time Frame: Before the first dose (pre) and one month after (post) the third dose ] [ Designated as safety issue: No ]
Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value [ Time Frame: Before the first dose (pre) and one month after (post) the third dose ] [ Designated as safety issue: No ]
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).
Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).
Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).
Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value [ Time Frame: One month after the third dose ] [ Designated as safety issue: No ]
Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.
Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value [ Time Frame: Four months after the administration of the second dose of Rotarix™ vaccine ] [ Designated as safety issue: No ]
Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).
Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day (Day 0-3) period after each dose ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting
Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 31-day (Day 0-30) period after each dose ] [ Designated as safety issue: No ]
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
Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: Up to one month after the third dose ] [ Designated as safety issue: No ]
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.

Enrollment:	230
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Synflorix group Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.	Biological: Synflorix Intramuscular injection, 3 doses. Other Name: Pneumococcal conjugate vaccine GSK1024850A Biological: Infanrix hexa Intramuscular injection, 3 doses. Other Name: DTPa-HBV-IPV/Hib Biological: Rotarix Oral, 2 doses. Other Name: HRV vaccine

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	6 Weeks to 8 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects between, and including 6-8 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s) or guardian(s) of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (BCG)).
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533507

Locations

Taiwan
GSK Investigational Site
Taipei, Taiwan, 105
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taoyuan Hsien, Taiwan

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Bermal N et al. Immunogenicity of a 10 valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine paediatric vaccines in Asian infants. Abstract presented at the 3rd Vaccine Congress. Singapore, Singapore, 4-6 October 2009.

Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lin TY, Lu CY, Chang LY, Chiu CH, Huang YC, Bock HL, Tang H, François N, Moreira M, Schuerman L, Huang LM. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. J Formos Med Assoc. 2012 Sep;111(9):495-503. doi: 10.1016/j.jfma.2011.07.014. Epub 2012 Mar 18.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00533507 History of Changes
Other Study ID Numbers:	109861
Study First Received:	September 20, 2007
Results First Received:	June 5, 2009
Last Updated:	January 5, 2012
Health Authority:	Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine.
Pneumococcal disease
Safety
Immunogenicity
Primary vaccination

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 13, 2013