Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273325
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2005-09-09
Brief Title:
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-low-birth-weight Infants
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCV-7
Brief Summary:
Premature infants are at a high risk for pneumonia The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants but was not thoroughly studied in premature infants This study evaluated the effectiveness and safety of the vaccine given in routine practice to very low birth weight infants looking at blood antibody levels 4-6 weeks after the final vaccine dose and adverse events survival infections and neurodevelopmental outcomes at 18-22 months corrected age
Detailed Description:
Streptococcus pneumoniae causes an estimated 10-25 of all pneumonias in the United States and is responsible for an estimated 40000 deaths per year Invasive pneumococcal disease has a peak incidence of 235100000 among children aged 6-11 months Pneumococcal meningitis carries a higher risk of death 15 or neurodevelopmental impairment 12-28 than Hib or Neisseria meningitides
Premature infants are at a higher risk for invasive disease with Streptococcus pneumoniae The heptavalent pneumococcal-CRM197 conjugate vaccine PCV-7 effectively prevents invasive pneumococcal disease in full-term infants but was been incompletely studied in premature infants The American Academy of Pediatrics AAP recommends that prematurely born infants including infants of low birth weight should be immunized at the usual chronological age in most cases but cautions that some studies suggest a reduced immune response in very low-birth-weight infants 1500 g
This observational study assessed the effectiveness of the PCV-7 vaccine to generate a sufficient immune response in a safe manner when given to very low birth weight VLBW infants in routine pediatric practice We hypothesized that among VLBW infants the frequency of estimated minimum protective antibody titers to PCV-7 015 μgmL would decrease with decreasing birth weight
Infants 501-1500g birth weight and 32 07 weeks gestational age were enrolled from nine NICHD Neonatal Research Network centers from 2004 to 2006 Enrollment was stratified by weight group to yield approximately 20 infants per 100g increments from 501-1500g birth weight whose primary PCV-7 series was initiated before 3 months and completed by 8 months after birth The infants primary providers gave PCV-7 vaccination at 2 4 and 6 months after birth Infants had a single 2-ml blood sample drawn 4-6 weeks following the third dose of PCV-7 Antibodies for each of the seven vaccine serotypes included in PCV-7 were measured by enzyme-linked immunosorbent assay Children were followed until 18-22 months corrected age to assess survival infection and neurodevelopmental outcomes
Premature infants are at a higher risk for invasive disease with Streptococcus pneumoniae The heptavalent pneumococcal-CRM197 conjugate vaccine PCV-7 effectively prevents invasive pneumococcal disease in full-term infants but was been incompletely studied in premature infants The American Academy of Pediatrics AAP recommends that prematurely born infants including infants of low birth weight should be immunized at the usual chronological age in most cases but cautions that some studies suggest a reduced immune response in very low-birth-weight infants 1500 g
This observational study assessed the effectiveness of the PCV-7 vaccine to generate a sufficient immune response in a safe manner when given to very low birth weight VLBW infants in routine pediatric practice We hypothesized that among VLBW infants the frequency of estimated minimum protective antibody titers to PCV-7 015 μgmL would decrease with decreasing birth weight
Infants 501-1500g birth weight and 32 07 weeks gestational age were enrolled from nine NICHD Neonatal Research Network centers from 2004 to 2006 Enrollment was stratified by weight group to yield approximately 20 infants per 100g increments from 501-1500g birth weight whose primary PCV-7 series was initiated before 3 months and completed by 8 months after birth The infants primary providers gave PCV-7 vaccination at 2 4 and 6 months after birth Infants had a single 2-ml blood sample drawn 4-6 weeks following the third dose of PCV-7 Antibodies for each of the seven vaccine serotypes included in PCV-7 were measured by enzyme-linked immunosorbent assay Children were followed until 18-22 months corrected age to assess survival infection and neurodevelopmental outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024128 | NIH | None | None |
| UL1RR024160 | NIH | None | None |
| UL1RR024982 | NIH | None | None |
| UL1RR025008 | NIH | None | None |
| UL1RR025744 | NIH | None | None |
| UL1RR025777 | NIH | None | None |
| M01RR016587 | NIH | None | None |
| M01RR000030 | NIH | None | None |
| M01RR000032 | NIH | None | None |
| M01RR000039 | NIH | None | None |
| M01RR000044 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| U01HD036790 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| U10HD040521 | NIH | None | None |
| U10HD040689 | NIH | None | httpsreporternihgovquickSearchU10HD040689 |