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Completed

NCT Number: NCT01521897

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

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°)

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Key information

Conditions

Pneumococcal Vaccine Streptococcus Pneumoniae

Age range

2 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yokoyama Children's Clinic

Kasuga, Fukuoka, 816-0801, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7-valent vaccine injection

Biological

For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.

Other names: Prevenar, 7vPnC

Primary outcomes

  1. Number of Participants With Adverse Reactions

    Time frame: 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 outcomes

  1. Number of Participants With Serious Adverse Events

    Time frame: 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.

  2. Number of Participants With Injection Site Reactions

    Time frame: 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".

  3. Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination

    Time frame: 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).

  4. Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination

    Time frame: 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).

Other outcomes

  1. Number of Participants by Month of Age at Each Vaccination Time

    Time frame: 28 days

    Number of participants was counted by month of age at each vaccination time (first to fourth).

  2. Number of Participants by Vaccination Sites at Each Vaccination Time

    Time frame: 28 days

    Number of participants was counted by vaccination sites at each vaccination time (first to fourth).

  3. Number of Participants by Pattern of Concomitant Vaccines

    Time frame: 28 days

    Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used 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).

  4. Number of Participants by Pattern of Concomitant Vaccination Sites

    Time frame: 28 days

    Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jan 31, 2012
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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