Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

NCT00825162 | Completed Phase 4 Results DMC

• 1 other identifier: CSLCT-USF-06-29
• Study Type: interventional
• Target: 1,992
• Locations: 1 country
• Sites: 7

Brief Summary

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged \>= 6 Months to \< 18 Years

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

• Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.

  7 days post-vaccination

• Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.

  7 days post-vaccination

• Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

  7 days post-vaccination

• Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

  7 days post-vaccination

• Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

  7 days post-vaccination

• Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)

  Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

  7 days post-vaccination

Secondary Outcomes (3)

• Frequency and Intensity of Unsolicited Adverse Events (UAEs)

  30 days after each study vaccination

• Frequency of Serious Adverse Events

  180 days after the last study vaccination

• Frequency of New Onsets of Chronic Illness

  180 days after the last study vaccination

Study Arms (3)

Cohort A

EXPERIMENTAL

Participants aged 6 months to less than 3 years

Biological: CSL Limited Influenza Virus Vaccine

Cohort B

EXPERIMENTAL

Participants aged 3 years to less than 9 years

Biological: CSL Limited Influenza Virus Vaccine

Cohort C

EXPERIMENTAL

Participants aged 9 years to less than 18 years

Biological: CSL Limited Influenza Virus Vaccine

Interventions

CSL Limited Influenza Virus Vaccine BIOLOGICAL

Single or two-vaccination regimen (0.25mL)

Cohort A

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female participants aged ≥ 6 months to \< 18 years at the time of vaccination;
• Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC;
• Good health, as determined by medical history, and a targeted physical examination;
• For participants aged \< 9 years, born after a normal gestation period (between 36 and 42 weeks);
• Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.

You may not qualify if:

• Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
• Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry;
• Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
• Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months;
• Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination;
• Pregnant or lactating females;
• Clinically significant medical or psychiatric conditions, as follows:
• For acute conditions (active or recent), the condition required hospitalisation within the last month; or
• For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
• i. requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or
• The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
• Confirmed or suspected immune deficiency (congenital or acquired, including cancer and human immunodeficiency virus infection);
• History of seizures, with the exception of a past history of a single seizure event at any age more than two years previously;
• Known history of Guillain-Barré Syndrome;
• Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6 months prior to administration of the Study Vaccine;

Sponsors & Collaborators

• Seqirus: lead

Study Sites (7)

The Canberra Hospital

Garran, Australian Capital Territory, 2606, Australia

Location

Sydney Children's Clinical Trials Centre

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Herston, Queensland, 4006, Australia

Location

Women's & Children's Hospital Adelaide

North Adelaide, South Australia, 5006, Australia

Location

Murdoch Children's Research Institute

Melbourne, Victoria, 3053, Australia

Location

Princess Margaret Hospital

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (1)

• Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, Reynolds GJ, Hartel GF, Hu W, Lai MH. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses. 2013 Sep;7(5):676-85. doi: 10.1111/irv.12107. Epub 2013 Apr 2.

  PMID: 23551933 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Study Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Stephen Lambert, Dr

  Royal Children's Hospital, Brisbane, Herston, QLD, Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 23, 2018
• Results First Posted: July 29, 2011

Record last verified: 2018-04

Locations

AU (7)