Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00496015

Purpose

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612).

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).

Condition	Intervention	Phase
Pneumococcal and Meningococcal Diseases.	Biological: Infanrix hexa. Drug: Paracetamol. Biological: Meningococcal vaccine GSK134612. Biological: Pneumococcal conjugate vaccine GSK1024850A.	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage

Resource links provided by NLM:

MedlinePlus related topics: Fever Flu

Drug Information available for: Acetaminophen CT 2584 Infanrix hexa Heptavalent pneumococcal conjugate vaccine Meningococcal Vaccines Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of core fever >= 38°C (rectal temperature) in the AP-AP, AP-NAP and NAP groups. [ Time Frame: Within 4 days after the administration of the vaccine dose. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited general adverse events. [ Time Frame: Within 4 days after the administration of the vaccine dose. ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after the administration of the vaccine dose. ] [ Designated as safety issue: No ]
Occurrence of serious adverse events. [ Time Frame: Throughout the entire study period. ] [ Designated as safety issue: No ]
Occurrence of adverse events specific to the meningococcal vaccine: rash, new onset of chronic illness, conditions prompting ER visits, in the unprimed group. [ Time Frame: Up to 6 months after the administration of the vaccine dose. ] [ Designated as safety issue: No ]
Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
Concentrations of antibodies against protein D. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
Occurrence of core fever > 39.0°C (rectal temperature). [ Time Frame: Within 4 days after the administration of the vaccine dose. ] [ Designated as safety issue: No ]
Occurrence of solicited local adverse events. [ Time Frame: Within 4 days after the administration of the vaccine dose. ] [ Designated as safety issue: No ]
Concentrations of antibodies against cross-reactive pneumococcal serotypes. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against cross-reactive pneumococcal serotypes. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
For subjects in the unprimed group, meningococcal serum bactericidal assay (rSBA) titres. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
For subjects in the unprimed group, anti-meningococcal polysaccharide concentrations. [ Time Frame: Prior to vaccination, one month post-vaccination and twelve months post-vaccination. ] [ Designated as safety issue: No ]
For subjects in the unprimed group, anti-tetanus toxoid and anti-hepatitis B surface antigen (HBs) antibody concentrations. [ Time Frame: Prior to vaccination. ] [ Designated as safety issue: No ]
Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-pertussis, anti-HBs antibody concentrations and anti-polio type 1, 2 and 3 titres. [ Time Frame: One month post-vaccination. ] [ Designated as safety issue: No ]
Anti-HBs antibody concentration and anti-polio type 1, 2 and 3 titres. [ Time Frame: Twelve months post-vaccination. ] [ Designated as safety issue: No ]
Occurrence of S. pneumoniae and/or H. influenzae in the nasopharynx. [ Time Frame: Prior to vaccination, one month post-vaccination, at 15-18 months of age, at 19-22 months of age and at 24-27 months of age. ] [ Designated as safety issue: No ]
Acquisition of new S. pneumoniae and/or H. influenzae strains in the nasopharynx. [ Time Frame: Prior to vaccination, one month post-vaccination, at 15-18 months of age, at 19-22 months of age and at 24-27 months of age. ] [ Designated as safety issue: No ]

Enrollment:	750
Study Start Date:	July 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Unprimed Group: Active Comparator Age-matched pneumococcal vaccine unprimed group receiving a single dose of meningococcal conjugate vaccine GSK134612 co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa).	Biological: Infanrix hexa. 1 intramuscular injection. Biological: Meningococcal vaccine GSK134612. 1 intramuscular injection.
AP-NAP Group: Experimental Subjects having received 3 primary vaccination doses with antipyretics and receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) without prophylactic antipyretics.	Biological: Infanrix hexa. 1 intramuscular injection. Biological: Pneumococcal conjugate vaccine GSK1024850A. 1 intramuscular injection.
NAP Group: Active Comparator Subjects having received 3 primary vaccination doses without antipyretics and receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) without prophylactic antipyretics.	Biological: Infanrix hexa. 1 intramuscular injection. Biological: Pneumococcal conjugate vaccine GSK1024850A. 1 intramuscular injection.
AP-AP Group: Experimental Subjects having received 3 primary vaccination doses with antipyretics and receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) with prophylactic antipyretics.	Biological: Infanrix hexa. 1 intramuscular injection. Drug: Paracetamol. Body weight of < 7 kg: none Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination. Biological: Pneumococcal conjugate vaccine GSK1024850A. 1 intramuscular injection.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	12 Months to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.
A male or female between, and including, 12-15 months of age at the time of the vaccination.
Written informed consent 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.

Subjects in the unprimed group

• A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.

Exclusion Criteria:

For all subjects:

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
Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the dose of study vaccines, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines.
Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines.
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Acute disease at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding administration of the dose of study vaccines or planned administration during the study period.
Subjects of which both parents have a history of atopia.
Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.

DTPa-HBV-IPV/Hib vaccine:

Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
Encephalopathy.
As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.

For subjects in the AP-AP, AP-NAP and NAP groups:

• Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.

For subjects in the AP-AP group:

• Subject with any contraindication to treatment with paracetamol.

For subjects in the unprimed group:

Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end.
Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.
History of meningococcal disease due to serogroup A, C, W, or Y.
Administration of any pneumococcal vaccine since birth.
Full vaccination history since birth not available.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496015

Locations

Czech Republic
GSK Investigational Site
Praha 5, Czech Republic, 150 00
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Praha 9, Czech Republic, 190 00
GSK Investigational Site
Praha 6, Czech Republic, 160 00
GSK Investigational Site
Znojmo, Czech Republic, 669 00
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Ostrava, Czech Republic, 728 92
GSK Investigational Site
Brno, Czech Republic, 628 00

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107137
Study First Received:	July 3, 2007
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00496015 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Fever
Prophylactic antipyretic
Pneumococcal vaccine
Pneumococcal disease
Meningococcal vaccine

Meningococcal disease
Safety
Immunogenicity
Carriage
Booster vaccination

Additional relevant MeSH terms:

Bacterial Infections
Physiological Effects of Drugs
Pharmacologic Actions
Gram-Negative Bacterial Infections
Analgesics, Non-Narcotic
Sensory System Agents
Meningococcal Infections

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen
Neisseriaceae Infections

ClinicalTrials.gov processed this record on February 09, 2010