Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Completed

Conditions: Streptococcus Pneumoniae
Pneumococcal Vaccine

Interventions: Biological: 7-valent vaccine injection

Registration Number: NCT01521897

Lead Sponsor: Pfizer

Brief Summary: This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.

This surveillance will specifically focus on the occurrence of the following:

1. Local reactions at the injection site

2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Detailed Description: This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1143

Inclusion Criteria

Infants at the age of more than 2 and less than 7 months
Infants who have been vaccinated with Prevenar for the first time
Infants expected to complete four vaccinations with Prevenar

Exclusion Criteria

Vaccination with Prevenar must not be given to any of the following;

History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
Evident pyrexia
Evident serious acute disease
Any other infants or children ineligible for vaccination

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
7-valent vaccine injection	7-valent vaccine injection	Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Reactions	28 days	An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Injection Site Reactions	28 days	Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for "injection site erythema"; induration for "injection site erythema" and "injection site swelling"; tenderness for "injection site pain"; and warmth for "injection site warmth".
Number of Participants With Serious Adverse Events	28 days	A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination	28 days	Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination	28 days	Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).