NCT00496015 - Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A | Crick

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 15 MonthsHealthy volunteers:

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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.

Outcomes

Primary Outcomes

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

The cut-off for core fever was 38.0 degrees Celsius (ºC).

Time frame: Within 4 days (Day 0-3) after primary vaccine dose.

Secondary Outcomes

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

The cut-off value for core fever (rectal temperature) was 39.0ºC.

Time frame: Within 4 days (Day 0-3) after primary vaccination dose

Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters (mm) from injection site.

Time frame: During the 4-day (Days 0-3) post-primary vaccination period

Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature \>40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.

Time frame: During the 4-day (Day 0-3) post-vaccination period

Number of Subjects Reported With Unsolicited Adverse Events (AEs)

The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within 31 days (Days 0-30) after primary vaccine dose.

Number of Subjects Reported With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: Throughout the entire study period (Month 0-Month 12)

Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

Time frame: Up to 6 months after vaccination with Mencevax™

Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).