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Optimizing primary vaccination schedule for premature infants

Optimizing primary vaccination schedule for premature infants - PRIEMA study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44869
Enrollment
300
Registered
2018-10-17
Start date
2015-10-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunogeniciteit bij prematuren ten aanzien van respons op de vaccinaties uit het RVP en de rotavirusvaccinatie antibody's immunogenicity

Interventions

antibody levels
preterm infants
vaccination

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: preterm infants, stratified in 3 groups (

Exclusion criteria

Exclusion criteria: not willing to let take blood

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint * Antibody levels against the regular NIP vaccine components (DTaP, IPV, HIb, HepB and PCV10) at 5 and 12 month of age in preterm infants.

Secondary

MeasureTime frame
Secondary study parameters/endpoints * Levels of maternal antibodies at 6 weeks of age * Cellular immunity at 12 month * Timelines of NIP vaccines * Tolerability and vaccine side effects * Rotavirus seroconversion rates and antibody levels at 5 an 12 month of age among those vaccinated

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)