Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants

NCT00213265 | Completed Phase 3

• 1 other identifier: 0020020011
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and effective in protecting children who have had a solid organ transplantation and healthy children from pneumococcal infections. We expect that two or more doses of Prevnar™ will result in similar antibody responses among transplant recipients compared with healthy control subjects, and that children who have undergone solid organ transplant will have a similar number of serious vaccine-related adverse events within 7 days after Prevnar™ as the healthy patients.

Conditions

Organ Transplant; Immunosuppression

Keywords

organ transplantation; immunosuppression; vaccine; pneumococcal conjugate vaccine; pediatrics

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Concentration of pneumococcal antibodies

  Transplant patients: at baseline, just before dose 3, and 6-8 weeks after dose 3; Controls: at baseline, just before dose 3, and 6-8 weeks after dose 3. For those whose series consisted of 1 or 2 doses, at baseline, and 6-8 weeks after doses 1 and 2.

• Serious vaccine related adverse events

  7 days post-vaccination

Secondary Outcomes (4)

• Nature of immune suppression

  24-28 weeks

• Presence of bacterial, viral or other opportunistic infections

  24-28 weeks

• Presence of rejection after enrollment

  24-28 weeks

• Presence of concurrent diseases or conditions including alterations of renal, hepatic, cardiac and bowel function

  24-28 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Biological: Pneumococcal 7-valent Conjugate Vaccine

2

EXPERIMENTAL

Biological: 7-valent pneumococcal conjugate vaccine

Interventions

7-valent pneumococcal conjugate vaccine BIOLOGICAL

For transplant patients, vaccination will be started at 4 months or greater after transplantation. The second dose will be given 8 weks following the frist, the third dose 8 weeks after the second, and the fourth will be given 8 weeks after the third.

Also known as: Prevnar

2

Pneumococcal 7-valent Conjugate Vaccine BIOLOGICAL

Healthy infants: The Prevnar schedule for healthy infants consists of 3 doses of 0.5 ml each, at approximately 2 month intervals, followed by a fourth dose of 0.5 ml at 12-15 months of age (i.e., 2, 4, 6, and 12-15 months) Previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, should receive the follwong schedule: 7-11 months of age: 3 doses (2 doses at least 4 weeks apart with the third dose after the first birthday and separated from the second dose by at least two months) 12-23 months of age: 2 doses (at least 2 months apart) ≥24 months through 9 years of age: 1 dose

Also known as: Prevnar

1

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Transplant recipients:
• Children 4 months of age up to 18 years of age
• received a kidney, liver, heart, lung or other solid organ transplantation in a Canadian transplant centre
• Informed consent obtained
• Healthy Infants and Children:
• Children 2 months to 9 years of age
• no underlying chronic medical conditions
• Informed consent obtained

You may not qualify if:

• Previous immunization with pneumococcal vaccine.
• Known hypersensitivity to any of the components of the vaccine, including diphtheria toxoid. Besides the saccharides and CRM197 carrier protein, the vaccine contains aluminum phosphate adjuvant.
• Any significant infection and/or fever at the time of vaccination
• Major acute illness such as clinical instability and acute graft rejection
• Latex allergy

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Upton Allen, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

• Upton Allen

  The Hospital for Sick Children

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Infectious Diseases

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2002
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

CA (1)