NEWS HIGHLIGHTS
Published Studies Related to M-M-R II (Measles / Mumps / Rubella Vaccine)
Antibody persistence in UK pre-school children following primary series with an acellular pertussis-containing pentavalent vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine. [2009.08.13]
This open-label, randomised, controlled study examined antibody persistence following infant vaccination at 2, 3 and 4 months of age with either an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Haemophilus influenzae type b (DT(5)aP-IPV-Hib; Pediacel) or a whole-cell pertussis (DTwP//Hib+oral poliomyelitis vaccine [OPV]) combination vaccine, given concomitantly with meningococcal serogroup C conjugate (MCC) vaccine, followed by a Hib booster at approximately 15 months of age...
Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial. [2009.08]
OBJECTIVE: The goal was to test a multifaceted distraction method designed to reduce injection-associated pain in school-aged children... CONCLUSION: This multifaceted distraction intervention reduced significantly the pain and discomfort of childhood immunizations in children 4 to 6 years of age.
Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. [2009.07]
The safety of a single injection of the refrigerator-stable formulation of varicella vaccine VARIVAX was assessed in a blind, randomized, cross-over trial... In summary, the refrigerator-stable formulation of VARIVAX had a good safety profile and was well tolerated in healthy children aged 12 to 15 months, consistent with experience with the frozen formulation of VARIVAX.
Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age. [2009.05.05]
Two doses of measles-mumps-rubella vaccine (MMR) are widely recommended and consideration is being given to a similar schedule for varicella vaccine. A combined measles-mumps-rubella-varicella vaccine (MMRV) could be considered for this second dose in children previously vaccinated separately with MMR and varicella vaccines...
Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. [2009.04.14]
BACKGROUND: When this trial was initiated, the combined measles, mumps and rubella (MMR) vaccine was licensed for subcutaneous administration in all European countries and for intramuscular administration in some countries, whereas varicella vaccine was licensed only for subcutaneous administration. This study evaluated the intramuscular administration of an MMR vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) compared with the subcutaneous route... CONCLUSION: The immunogenicities of M-M-RvaxPro and VARIVAX administered by the intramuscular route were comparable with those following subcutaneous administration, and the tolerability of the two vaccines was comparable regardless of administration route. Integration of both administration routes in the current European indications for the two vaccines will now allow physicians in Europe to choose their preferred administration route in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT00432523.
Clinical Trials Related to M-M-R II (Measles / Mumps / Rubella Vaccine)
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route [Completed]
Primary objective:
To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of
age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as
immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates
to measles, mumps and rubella at 42 days following the vaccination.
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of
age using separate injection sites, a single dose of VARIVAX® administered by IM route is as
immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate
to varicella at 42 days following the vaccination
Secondary objectives:
- To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days
following the vaccination in children immunised with M-M-R™II and VARIVAX® administered
concomitantly at two separate injection sites by the same route IM or SC,
- To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at
two separate injection sites by the same route IM or SC.
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age [Recruiting]
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines
(manufactured by GSK and Merck and Company ) in terms of the immune response elicited and
safety with a six month follow-up after first vaccination. Additionally, antibody
persistence will be assessed one and two years after administration of MMR vaccine
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) [Not yet recruiting]
This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured
with the 2007 commercial VZV bulk process when concomitantly administered with M-M-R II in
healthy children
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety. [Completed]
The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals'
combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when
administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years
when co-administered with MMR vaccine in subjects who had previously received four doses of
Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.
A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group [Active, not recruiting]
To compare measles seroconversion rates (development of antibodies) at 13 months of age in
HIV-infected and uninfected children on one of two immunization schedules: attenuated
measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine
(Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.
Recommendations for the age at vaccination should balance the need to minimize the risk of
morbidity and mortality with the benefit of achieving the highest seroconversion rates.
Immunizing a more intact immune system at an earlier stage of HIV infection may in turn
achieve better and long-lasting measles protection. This study will help define a more
effective measles vaccine regimen for children diagnosed with HIV infection and will provide
greater insight into the functional status of the HIV-infected children's humoral immune
system.
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